ODC
- Product code
- ODC
- Device name
- Endoscope Channel Accessory
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 21
- Summaries archived here
- 18 (direct download)
- 510(k) clearances (all years, FDA)
- 72 (all years; only the last 3 years are listed here)
FDA classification definition
To give the endoscope channel additional or improved functionality.
510(k) clearances, last 3 years (21)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252933 | 2026-06-12 | Dyne Medical Group, Inc. | DYNE PORT | |
| K250145 | 2025-10-17 | Endosound, Inc. | Biopsy Port Adapter | |
| K252910 | 2025-10-09 | Boston Scientific | Orca Air/Water and Suction Valves | |
| K250949 | 2025-07-16 | Olympus Medical Systems Corporation | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | |
| K250732 | 2025-06-20 | Yangzhou Fartley Medical Instrument Te… | Disposable Endoscopy Valve Set | |
| K241842 | 2025-03-19 | Olympus Medical Systems Corporation | Luer-Split MAJ-2092 | |
| K250140 | 2025-02-20 | Steris Corparation | Defendo Fujifilm 700 Single Use Cleaning Adapter | |
| K243075 | 2024-11-08 | STERIS Corporation | Defendo Single Use Cleaning Adapter for Olympus Endo… | FDA |
| K242742 | 2024-10-11 | STERIS Corporation | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for O… | |
| K241285 | 2024-10-01 | Alton (Shanghai) Medical Instruments C… | Disposable Endoscope Valves Set (AF series) | |
| K232067 | 2024-03-22 | Medivators (A Subsidiary of Steris Cor… | Defendo Fujifilm 500/600 Single Use Air/Water Valve,… | |
| K232327 | 2024-03-15 | Endostart S.R.L. | Endorail | |
| K240352 | 2024-03-06 | STERIS Corporation | Defendo Single Use Cleaning Adapter for Olympus Endo… | |
| K232004 | 2024-03-06 | Medivators (A Subsidiary of Steris Cor… | Defendo Pentax Single Use Biopsy Valve, Defendo Pent… | FDA |
| K240098 | 2024-02-09 | STERIS Corporation | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for O… | |
| K232329 | 2023-12-21 | Medivators (A Subsidiary of Steris Cor… | Defendo Fujifilm 700 Single Use Biopsy Valve; Defend… | |
| K232249 | 2023-12-01 | Pentax of America, Inc. | PENTAX Medical Gas/Water Feeding Valve OE-B14 | |
| K232244 | 2023-11-29 | Changzhou Endoclean Medical Device Co.… | Disposable Endoscope Valves System | |
| K222499 | 2023-11-22 | Shanghai SeeGen Photoelectric Technolo… | Disposable Endoscope Valves Kit | |
| K232951 | 2023-10-20 | Steris | BioShield Biopsy Valve (00711124); BioShield Biopsy … | |
| K232118 | 2023-10-16 | Ga Health Company Limited | ANDORATE® Valve Kit | FDA |
Official FDA classification page: ODC
Classification and pathway per current FDA publications. Data from openFDA (CC0).