Panels › Gastroenterology, Urology › Product code OCU · Class 2
Endoscopic Storage Cover
Regulation 876.1500
0510(k)s in 12 months (6 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in OCU
| Company | 510(k)s | Recalls |
|---|---|---|
| Acmi Corporation | 1 | 0 |
| Fibertech Instruments, Inc. | 1 | 0 |
| Ga Health Company Limited | 1 | 0 |
| Healthmark Industries Co., Inc. | 0 | 1 |
| Meditech Endoscopy, Ltd. | 1 | 0 |
| STERIS Corporation | 1 | 0 |
| United States Endoscopy Group, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2026 | Healthmark Industries Co., Inc. Mesh Style Tip Protectors
CSW-03-2.0 Open-end style
CSW-04-4.0 Closed-end style Open, Classified |
OCU | None listed |
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