Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15
FDA 510(k) K090116 · Fujinon, Inc.
510(k) numberK090116
Submission
- Device name
- Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15
- Applicant
- Fujinon, Inc.
Kita- Ku Saitama, JP - Received
- January 21, 2009
- Decision date
- April 22, 2009
- 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).
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| 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 |
|---|---|---|
| K120446 | Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2FDS · Traditional | 08/13/2012SE |
| K112391 | Fujinon ColonoscopesFDF · Special | 07/26/2012SE |
| K102466 | Fujinon EPX-4440HD Digital Video ProcessorFET · Traditional | 05/25/2011SE |
| K111243 | Fujinon Ultrasonic ProcessorFDS · Special | 05/16/2011SE |
| K091773 | Fujinon Sterile OvertubesFED · Special | 08/07/2009SE |
| K063316 | Fujinon Model EG-530N Trans Nasal InsertionFDS · Traditional | 03/16/2007SE |
| K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700FDS · Traditional | 03/01/2007SE |
| K050907 | Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PEOQ · Traditional | 05/19/2005SE |
| K042043 | Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5FDS · Traditional | 11/24/2004SE |
| K042076 | Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5FDT · Traditional | 11/18/2004SE |
Questions and answers
When was Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 cleared by the FDA?
Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 (K090116) received a 510(k) decision of Substantially Equivalent on April 22, 2009, 91 days after the submission was received.
What is the product code of K090116?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.