Panels › Gastroenterology, Urology › Product code ODC · Class 2
Endoscope Channel Accessory
Regulation 876.1500
1510(k)s in 12 months (72 all time)
3recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in ODC
| Company | 510(k)s | Recalls |
|---|---|---|
| STERIS Corporation | 7 | 0 |
| Boston Scientific | 3 | 1 |
| Byrne Medical Incorporated | 4 | 0 |
| Ga Health Company Limited | 4 | 0 |
| Medivators (A Subsidiary of Steris Corporation) | 3 | 0 |
| Smart Medical Systems , Ltd. | 3 | 0 |
| United States Endoscopy Group, Inc. | 3 | 0 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 3 | 0 |
| Changzhou Endoclean Medical Device Co., Ltd. | 2 | 0 |
| Cook Incorporated | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2026 | Boston Scientific Corporation Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastroint Open, Classified |
ODC | K252910 |
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. Open, Classified |
ODC | K250949 |
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. Open, Classified |
ODC | K250949 |
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