Pentax Video Colonoscopes (Ec Family)
FDA 510(k) K131855 · Pentax Medical Company
510(k) numberK131855
Submission
- Device name
- Pentax Video Colonoscopes (Ec Family)
- Applicant
- Pentax Medical Company
Montvale, NJ, US - Received
- June 21, 2013
- Decision date
- April 9, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDF – Colonoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- 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).
Other 510(k)s with product code FDF
| 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 |
More from Actuated Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K192280 | PENTAX Medical ED-3490TK Video DuodenoscopeFDT · Traditional | 10/21/2019SE |
| K171011 | PENTAX Medical VIVIDEO ENT Videoscope SolutionEOB · Traditional | 07/18/2018SE |
| K172156 | PENTAX Medical EPK-3000 Video Imaging SystemEOB · Traditional | 04/05/2018SE |
| K161222 | PENTAX MEDICAL ED-3490TK, Video DuodenoscopeFDT · Traditional | 02/07/2018SE |
| K163614 | PENTAX Medical ED34-i10T, Video DuodenoscopeFDT · Traditional | 09/20/2017SE |
| K131946 | Entax Ultrasound Video Bronchoscope EB-1970UK + Hi Visin PreirusEOQ · Traditional | 04/25/2014SE |
| K131902 | Pentax Video Upper G.I. Scopes (Eg Family)FDS · Traditional | 04/10/2014SE |
| K131028 | Pentax Video Bronchoscopes (Eb Family)EOQ · Traditional | 04/10/2014SE |
| K122470 | Pentax EPK-I5010 Video ProcessorPEA · Traditional | 04/10/2013SE |
| K093037 | Pentex EC-3890LIFDF · Traditional | 12/28/2009SE |
Questions and answers
When was Pentax Video Colonoscopes (Ec Family) cleared by the FDA?
Pentax Video Colonoscopes (Ec Family) (K131855) received a 510(k) decision of Substantially Equivalent on April 9, 2014, 292 days after the submission was received.
What is the product code of K131855?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.