Colonoscope And Accessories, Flexible/Rigid
FDA product code FDF · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
115510(k) clearances
0PMA approvals
24recalls
Manufacturers
- Pentax Precision Instrument Corp. 11
- Motus GI Medical Technologies , Ltd. 7
- Olympus Medical Systems Corp. 7
- Avantis Medical Systems, Inc. 6
- Lumendi, LLC 6
- Smart Medical Systems , Ltd. 5
- Fujifilm Medical Systems U.S.A, Inc. 5
- Fujifilm Corporation 5
- Gi View , Ltd. 4
- Fujinon, Inc. 3
- Easyglide , Ltd. 2
- Pentax Medical Company 2
- Neoguide Systems, Inc. 2
- United States Endoscopy Group, Inc. 2
- Invendo Medical GmbH 2
- The Olympus Optical Co. 2
- Peermedical 2
- Medrobotics Corporation 2
- Invendo Medical Gbmh 2
- American Optical Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260503 | Triton 1 SystemFDF · Traditional | Neptune Medical, Inc. | 09/03/2026SE |
| K261015 | Solo Scope Colonoscope SystemFDF · Traditional | Gi View, Ltd. | 08/21/2026SE |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101)FDF · Special | BPEndo, LLC | 07/02/2026SE |
| K260423 | Disposable Endoscopic Distal AttachmentsFDF · Traditional | Yangzhou Fartley Medical Instrument Technology… | 05/28/2026SE |
| K252457 | Disposable Distal End Tape HoodFDF · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 01/30/2026SE |
| K244029 | Robopera (ER-R-002); Robopera (ER-R-003)FDF · Traditional | Endorobotics Co., Ltd. | 09/24/2025SE |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…FDF · Traditional | Fujifilm Corporation | 05/23/2025SE |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…FDF · Traditional | Olympus Medical Systems Corporation | 05/15/2025SE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF · Traditional | Pentax of America, Inc. | 01/03/2025SE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF · Traditional | Actuated Medical, Inc. | 10/04/2024SE |
| K232043 | Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C…FDF · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 02/16/2024SE |
| K231254 | GripTract-GI Endoscopic Tissue ManipulatorFDF · Traditional | Actuated Medical, Inc. | 11/03/2023SE |
| K232922 | Pure-Vu EVS SystemFDF · Special | Motus GI Medical Technologies , Ltd. | 10/20/2023SE |
| K230332 | Ambu® aScope Colon; Ambu® aBox 2FDF · Traditional | Ambu A/S | 09/15/2023SE |
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01FDF · Traditional | Fujifilm Corporation | 09/08/2023SE |
| K230588 | Aer-O-Scope Colonoscope SystemFDF · Traditional | Gi View , Ltd. | 08/17/2023SE |
| K221452 | DiLumen C1, EZ1 and Tool MountFDF · Traditional | Lumendi, LLC | 02/10/2023SE |
| K213773 | Insufflation Retention DeviceFDF · Traditional | Bpendo, LLC | 07/21/2022SE |
| K220158 | G-EYE SystemFDF · Traditional | Smart Medical Systems , Ltd. | 04/11/2022SE |
| K213578 | Balloon Dilatation CatheterFDF · Traditional | Hangzhou AGS MedTech Co., Ltd. | 04/06/2022SE |
| K210052 | Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without…FDF · Traditional | Saneso, Inc. | 04/01/2022SE |
| K220007 | Pure-Vu EVS SystemFDF · Special | Motus GI Medical Technologies , Ltd. | 02/10/2022SE |
| K211819 | DiLumen C2 and Tool MountFDF · Traditional | Lumendi, LLC | 10/22/2021SE |
| K210981 | Pure Vu SystemFDF · Special | Motus GI Medical Technologies , Ltd. | 04/29/2021SE |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen)FDF · Special | Lumendi, LLC | 04/21/2021SE |
| K202469 | G-EYE SystemFDF · Traditional | Smart Medical Systems , Ltd. | 10/26/2020SE |
| K192793 | Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…FDF · Traditional | Olympus Medical Systems Corp. | 07/17/2020SE |
| K192588 | G-EYE SystemFDF · Traditional | Smart Medical Systems , Ltd. | 04/15/2020SE |
| K190669 | EndoticsFDF · Traditional | Era Endoscopy S.R.L. | 01/03/2020SE |
| K192664 | FUJIFILM Endoscope Model EC-760Z-V/LFDF · Traditional | Fujifilm Corporation | 11/20/2019SE |
| K191220 | Pure Vu SystemFDF · Special | Motus GI Medical Technologies , Ltd. | 06/06/2019SE |
| K190649 | FUJIFILM Endoscope Model EC-760S-V/LFDF · Special | Fujifilm Corporation | 05/07/2019SE |
| K181084 | PENTAX Video Colonoscopes (EC Family)FDF · Traditional | Pentax of America, Inc. | 01/18/2019SE |
| K182540 | DiLumen Endolumenal Interventional PlatformFDF · Traditional | Lumendi, LLC | 10/30/2018SE |
| K180285 | PENTAX Medical Video Colonoscope EC34-i10T SeriesFDF · Traditional | Pentax Medical of America, Inc. | 10/26/2018SE |
| K181437 | Pure Vu SystemFDF · Special | Motus GI Medical Technologies , Ltd. | 06/21/2018SE |
| K173317 | DiLumen C2; DiLumen Tool MountFDF · Traditional | Lumendi, LLC | 04/17/2018SE |
| K180405 | FUJIFILM Endoscope Models EC-600HL and EC-600LSFDF · Special | Fujifilm Corporation | 03/15/2018SE |
| K171673 | Focus CapFDF · Traditional | Gce Medical Corporation | 01/19/2018SE |
| K173085 | invendoscopy E210 SystemFDF · Traditional | Invendo Medical GmbH | 01/08/2018SE |
| K173392 | Pure-Vu SystemFDF · Special | Motus GI Medical Technologies , Ltd. | 12/12/2017SE |
| K172036 | Medrobotics Flex Robotic SystemFDF · Special | Medrobotics Corporation | 08/03/2017SE |
| K162330 | Flex Robotic System and Flex Colorectal DriveFDF · Traditional | Medrobotics Corporation | 05/04/2017SE |
| K163492 | Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon…FDF · Special | United States Endoscopy Group, Inc. | 01/06/2017SE |
| K162428 | DiLumen Endolumenal Interventional PlatformFDF · Traditional | Lumendi, LLC | 12/06/2016SE |
| K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LSFDF · Special | Fujifilm Medical Systems U.S.A, Inc. | 10/18/2016SE |
| K160015 | Pure VuFDF · Traditional | Motus GI Medical Technologies , Ltd. | 09/22/2016SE |
| K161355 | invendoscopy E200 SystemFDF · Traditional | Invendo Medical GmbH | 08/25/2016SE |
| K161791 | Aer-O-Scope Colonoscope SystemFDF · Traditional | Gi View , Ltd. | 08/11/2016SE |
| K160356 | Third Eye Panoramic Auxiliary Endoscopy System - ResposableFDF · Traditional | Avantis Medical Systems, Inc. | 05/17/2016SE |
| K160196 | Fujifilm Video Colonoscope Model EC-600WL V2FDF · Special | Fujifilm Medical Systems U.S.A, Inc. | 02/23/2016SE |
| K153483 | Balloon controller PB-30FDF · Special | Fujifilm Medical Systems U.S.A, Inc. | 12/15/2015SE |
| K143732 | FUJIFILM Endoscope Models EC-600HL and EC-600LSFDF · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 07/06/2015SE |
| K140595 | Third Eye Panoramic Auxiliary Endoscopy SystemFDF · Traditional | Avantis Medical Systems, Inc. | 11/17/2014SE |
| K141598 | Fuse Colonoscopy SystemFDF · Special | Endochoice, Inc. | 09/30/2014SE |
| K141286 | Aer-O-Scope Colonoscope SystemFDF · Traditional | Gi View , Ltd. | 09/30/2014SE |
| K131855 | Pentax Video Colonoscopes (Ec Family)FDF · Traditional | Pentax Medical Company | 04/09/2014SE |
| K132839 | Fuse 1C Colonoscopy SystemFDF · Traditional | Endochoice, Inc. | 02/06/2014SE |
| K132210 | Fujifilm 600 Series EndoscopesFDF · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 01/10/2014SE |
| K131780 | Evis Exera III Video SystemFDF · Special | Olympus Medical Systems Corp. | 08/29/2013SE |
| K130718 | Peerscope SystemFDF · Special | Peermedical , Ltd. | 04/16/2013SE |
| K121582 | Invendo C25 Colonoscopy SystemFDF · Special | Invendo Medical Gbmh | 12/20/2012SE |
| K120289 | Peerscope SystemFDF · Traditional | Peermedical | 09/28/2012SE |
| K112391 | Fujinon ColonoscopesFDF · Special | Fujinon, Inc. | 07/26/2012SE |
| K113050 | Clearpath Lower GiFDF · Special | Easyglide , Ltd. | 05/16/2012SE |
| K111756 | V1 SystemFDF · Traditional | Olympus Medical Systems Corp. | 03/20/2012SE |
| K100624 | Invendo C20 Colonoscopy SystemFDF · Traditional | Invendo Medical Gbmh | 02/23/2012SE |
| K112680 | Evis Exera III Video SystemFDF · Traditional | Olympus Medical Systems Corporation | 02/16/2012SE |
| K111028 | Eus BalloonFDF · Traditional | United States Endoscopy Group, Inc. | 11/01/2011SE |
| K103312 | UPD-Y0003FDF · Traditional | Olympus Medical Systems Corporation | 05/12/2011SE |
| K102616 | Naviaid Balloon Guided Colonoscopy (BGC) DeviceFDF · Traditional | Smart Medical Systems , Ltd. | 12/30/2010SE |
| K100966 | Colonoscope/Sigmoidoscope SheathesFDF · Traditional | Sheathing Technologies, Inc. | 08/03/2010SE |
| K101191 | Naviaid Icvi DeviceFDF · Traditional | Smart Medical Systems , Ltd. | 07/27/2010SE |
| K101053 | Olympus CF Type Y0023-L, Y0023IFDF · Traditional | Olympus Medical Systems Corporation | 07/14/2010SE |
| K093037 | Pentex EC-3890LIFDF · Traditional | Pentax Medical Company | 12/28/2009SE |
| K093187 | Modification to Third Eye Retroscope Auxiliary Endoscopy SystemFDF · Special | Avantis Medical Systems, Inc. | 11/05/2009SE |
| K091305 | ClearpathFDF · Traditional | Easyglide , Ltd. | 10/23/2009SE |
| K091783 | Third Eye Retroscope Auxiliary Endoscope SystemFDF · Special | Avantis Medical Systems, Inc. | 07/07/2009SE |
| K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15FDF · Traditional | Fujinon, Inc. | 04/22/2009SE |
| K083180 | Third Eye Retroscope Auxiliary Endoscopy SystemFDF · Traditional | Avantis Medical Systems, Inc. | 02/12/2009SE |
| K081004 | Protectiscope CS Colonoscope, Non-IntrapullFDF · Special | Stryker GI | 05/02/2008SE |
| K080317 | Enolok-For Endoscoped with 12.8>DIA.<13.3MM Shaft Diameter, Model Ael; Endoscopes with…FDF · Traditional | Syntheon, LLC | 04/29/2008SE |
| K070622 | Neoguide Endoscopy SystemFDF · Traditional | Neoguide Systems, Inc. | 08/14/2007SE |
| K070330 | Third Eye Retroscope Auxiliary Endoscopy SystemFDF · Traditional | Avantis Medical Systems, Inc. | 04/24/2007SE |
| K063654 | EndoguideFDF · Traditional | Kms Medical, LLC | 01/31/2007SE |
| K063585 | Karl Storz Video Lower G.I. Endoscope SystemFDF · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/31/2007SE |
| K052930 | Navigator Endoscopy SystemFDF · Traditional | Neoguide Systems, Inc. | 01/31/2006SE |
| K051068 | Zutron Colonoscope Stiffening DeviceFDF · Traditional | Zutron Medical | 07/11/2005SE |
| K051541 | GF-UE160-AL5 Ultrasound EndoscopeFDF · Traditional | Olympus America, Inc. | 07/01/2005SE |
| K043487 | Evis Exera Colonovideoscope Model XCF-Q160W1L/1FDF · Traditional | Aizu Olympus Co., Ltd. | 01/28/2005SE |
| K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5FDF · Traditional | Fujinon, Inc. | 11/10/2004SE |
| K032688 | Colonosight Model 510BFDF · Traditional | Sightline Technologies , Ltd. | 03/05/2004SE |
| K023259 | Inhealth Soft Sleeve Colonoscope Splint, Model CS1200FDF · Traditional | Helix Medical, Inc. | 12/26/2002SE |
| K002749 | Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model XCF-Q140L/13DFDF · Traditional | The Olympus Optical Co. | 12/04/2000SE |
| K001241 | Evis Exera Colonovideoscope CF-Q160 Al/I and PCF-160 Al/IFDF · Special | The Olympus Optical Co. | 05/09/2000SE |
| K970372 | Gastroscope and Colonoscope Nozzle Replacement KitsFDF · Traditional | Precision Endoscopy of America, Inc. | 03/11/1997SE |
| K961570 | KEC-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length)FDF · Traditional | Pentax Precision Instrument Corp. | 06/24/1996SE |
| K961563 | EC-384OTL, Video ColonscopeFDF · Traditional | Pentax Precision Instrument Corp. | 06/19/1996SE |
| K951579 | EC-3800TL, Video ColonoscopeFDF · Traditional | Pentax Precision Instrument Corp. | 03/21/1996SE |
| K951574 | EC-3800L, Video ColonoscopeFDF · Traditional | Pentax Precision Instrument Corp. | 03/21/1996SE |
| K954704 | VS-200 Video SigmoidoscopeFDF · Traditional | Welch Allyn, Inc. | 03/07/1996SE |
| K951580 | FC-38LH, Fiber ColonosccopeFDF · Traditional | Pentax Precision Instrument Corp. | 06/27/1995SE |
| K951578 | FC-38LX, Fiber ColonoscopeFDF · Traditional | Pentax Precision Instrument Corp. | 06/27/1995SE |
| K951575 | FC-38TLH, Fiber ColonoscopeFDF · Traditional | Pentax Precision Instrument Corp. | 06/27/1995SE |
| K943895 | Vision System ColonscopeFDF · Traditional | Vision-Sciences, Inc. | 02/03/1995SE |
| K901610 | Sullivan Variable Stiffness CableFDF · Traditional | Wilson-Cook Medical, Inc. | 06/29/1990SE |
| K884857 | Colonoscope Guiding Tube DeviceFDF · Traditional | Mill-Rose Laboratory | 03/17/1989SE |
| K822846 | Pentax FC-38LA & FC-38SA ColonofiberFDF · Traditional | Pentax Precision Instrument Corp. | 10/22/1982SE |
| K810682 | Pentax Colonoscope Model FC-34LAFDF · Traditional | Pentax Precision Instrument Corp. | 04/03/1981SE |
| K810791 | Pentax Colonoscope Model FC-34 MaFDF · Traditional | Pentax Precision Instrument Corp. | 03/31/1981SE |
| K810654 | Stopperless Hot/Cold Rubber Water BottleFDF · Traditional | First Industries, Inc. | 03/27/1981SE |
| K801223 | Pentex Fexible Colonscope, Mod. FC-34AFDF · Traditional | Pentax Precision Instrument Corp. | 06/09/1980SE |
| K792179 | Ao Flexible Fiber Optic S/ColonoscopeFDF · Traditional | American Optical Corp. | 12/06/1979SE |
| K790338 | Colonoscope, Model SC-4 Flexible FiberFDF · Traditional | American Optical Corp. | 04/04/1979SE |
| K760452 | Colonoscope, 2-CHANNEL Log (Acmi TX-92)FDF · Traditional | American Cystocope Makers, Inc. | 08/30/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1211-2024 Class II | Colonoscope, Model Number PCF-H190L.Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain… | Olympus Corporation of the Americas | 01/11/2024Open, Classified |
| Z-1207-2024 Class II | Colonoscope, Model Number CF-HQ190L.Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain… | Olympus Corporation of the Americas | 01/11/2024Open, Classified |
| Z-1206-2024 Class II | Colonoscope, Model Number CF-HQ190I.Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain… | Olympus Corporation of the Americas | 01/11/2024Open, Classified |
| Z-0419-2024 Class II | PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPESpecific devices may have an improperly repaired light guide connector due to missing adhesive to secure the… | Aizu Olympus Co., Ltd. | 10/16/2023Open, Classified |
| Z-0418-2024 Class II | PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPESpecific devices may have an improperly repaired light guide connector due to missing adhesive to secure the… | Aizu Olympus Co., Ltd. | 10/16/2023Open, Classified |
| Z-0417-2024 Class II | GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPESpecific devices may have an improperly repaired light guide connector due to missing adhesive to secure the… | Aizu Olympus Co., Ltd. | 10/16/2023Open, Classified |
| Z-0416-2024 Class II | GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPESpecific devices may have an improperly repaired light guide connector due to missing adhesive to secure the… | Aizu Olympus Co., Ltd. | 10/16/2023Open, Classified |
| Z-0415-2024 Class II | CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPESpecific devices may have an improperly repaired light guide connector due to missing adhesive to secure the… | Aizu Olympus Co., Ltd. | 10/16/2023Open, Classified |
| Z-0288-2024 Class II | EVIS EXERA III Gastrointestinal VideoscopeSterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time… | Olympus Corporation of the Americas | 10/02/2023Open, Classified |
| Z-0334-2024 Class II | Gastrointestinal videoscope-indicated for use within the upper digestive tract…Channel air drying process was not validated, and that a small percentage of scopes returned to customers… | Aizu Olympus Co., Ltd. | 09/25/2023Open, Classified |
| Z-0056-2025 Class II | EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS…Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the… | Olympus Corporation of the Americas | 09/14/2023Open, Classified |
| Z-1274-2022 Class II | Colonovideoscope Model CF-H180ALA (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL… | Olympus Corporation of the Americas | 04/22/2022Terminated |
| Z-2449-2021 Class II | Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i…Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and… | Pentax of America Inc | 07/14/2021Open, Classified |
| Z-2448-2021 Class II | Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel…Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and… | Pentax of America Inc | 07/14/2021Open, Classified |
| Z-0507-2021 Class II | Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for…A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU)… | Olympus Corporation of the Americas | 10/16/2020Terminated |
| Z-1268-2020 Class II | Pentax Video Colonoscope Model: EC38-i10LDistributed in the USA without an approved 510K | Pentax of America Inc | 01/03/2020Terminated |
| Z-1267-2020 Class II | Pentax Video Colonoscope Model: EC34-i10LDistributed in the USA without an approved 510K | Pentax of America Inc | 01/03/2020Terminated |
| Z-1192-2019 Class II | Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of…The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. | Medrobotics Corporation | 01/25/2019Terminated |
| Z-1191-2019 Class II | Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of…The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. | Medrobotics Corporation | 01/25/2019Terminated |
| Z-0636-2017 Class II | Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including…Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were… | Pentax of America Inc | 08/15/2016Terminated |
| Z-2278-2016 Class II | Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic…Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle… | Pentax Medical Company | 04/06/2016Terminated |
| Z-2275-2016 Class II | Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic…Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle… | Pentax Medical Company | 04/06/2016Terminated |
| Z-2068-2016 Class II | Colonoscope Intended to provide optical visualization of and therapeutic access to the…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | Pentax Medical Company | 04/06/2016Terminated |
| Z-0694-2016 Class II | Fuse 1C ColonoscopeThe bending section of the device may partially separate from the insertion tube. Potential for tissue trauma. | EndoChoice, Inc. | 12/18/2015Terminated |