ODC — Endoscope Channel Accessory Class II
FDA product code ODC covers "Endoscope Channel Accessory", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ODC
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To give the endoscope channel additional or improved functionality.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252933 | dyne medical group | DYNE PORT | June 12, 2026 |
| K250145 | endosound | Biopsy Port Adapter | October 17, 2025 |
| K252910 | boston scientific | Orca Air/Water and Suction Valves | October 9, 2025 |
| K250949 | olympus medical systems corporation | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | July 16, 2025 |
| K250732 | yangzhou fartley medical instrument technology co | Disposable Endoscopy Valve Set | June 20, 2025 |
| K241842 | olympus medical systems corporation | Luer-Split MAJ-2092 | March 19, 2025 |
| K250140 | steris corparation | Defendo Fujifilm 700 Single Use Cleaning Adapter | February 20, 2025 |
| K243075 | steris corporation | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 | November 8, 2024 |
| K242742 | steris corporation | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | October 11, 2024 |
| K241285 | alton (shanghai) medical instruments co | Disposable Endoscope Valves Set (AF series) | October 1, 2024 |
| K232067 | medivators (a subsidiary of steris corporation) | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Si | March 22, 2024 |
| K232327 | endostart | Endorail | March 15, 2024 |
| K232004 | medivators (a subsidiary of steris corporation) | Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valv | March 6, 2024 |
| K240352 | steris corporation | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | March 6, 2024 |
| K240098 | steris corporation | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | February 9, 2024 |
| K232329 | medivators (a subsidiary of steris corporation) | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Ai | December 21, 2023 |
| K232249 | pentax of america | PENTAX Medical Gas/Water Feeding Valve OE-B14 | December 1, 2023 |
| K232244 | changzhou endoclean medical device co | Disposable Endoscope Valves System | November 29, 2023 |
| K222499 | shanghai seegen photoelectric technology co | Disposable Endoscope Valves Kit | November 22, 2023 |
| K232951 | steris | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield | October 20, 2023 |