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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 2021 | K202838 | Andorate Universal Endoscope Tip Guard Ga Health Company Limited, CN | OCU |
| Jan 27, 2020 | K191715 | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile STERIS Corporation | OCU |
| May 7, 2019 | K191011 | Scope ProTech Meditech Endoscopy, Ltd., GB | OCU |
| Jun 3, 2003 | K030684 | SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH Acmi Corporation | OCU |
| Apr 6, 1995 | K951104 | ENDOBOOT United States Endoscopy Group, Inc. | OCU |
| May 10, 1994 | K940780 | SCOPEJOCKEY Fibertech Instruments, Inc. | OCU |
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