ODC — Endoscope Channel Accessory Class II
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 |
|---|---|---|---|
| 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 |
| K232118 | ga health company limited | ANDORATE® Valve Kit | October 16, 2023 |