Panels › Gastroenterology, Urology › Product code GCP · Class 2
Endoscope, Ac-Powered And Accessories
Regulation 876.1500
0510(k)s in 12 months (13 all time)
2recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in GCP
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus Corporation of the Americas | 0 | 5 |
| Propper Mfg. Co., Inc. | 3 | 0 |
| American Endoscopy, Inc. | 1 | 0 |
| Endotherapeutics | 1 | 0 |
| Endovations | 1 | 0 |
| Medical Dynamics, Inc. | 1 | 0 |
| North Eos Industries, Inc. | 1 | 0 |
| Olympus Corp. | 1 | 0 |
| Porges Corp. | 1 | 0 |
| Reichert Scientific Instruments | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2026 | Olympus Corporation of the Americas Olympus Cystoscope Outer Sheath;
Model/Catalog number: WA22810A; Open, Classified |
GCP | K790071 |
| Feb 20, 2026 | Olympus Corporation of the Americas Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications. Open, Classified |
GCP | K790071 |
| Nov 8, 2024 | Olympus Corporation of the Americas Brand Name: Olympus
Product Name: Cystoscope Outer Sheath
Model/Catalog Number: WA22810A
Software Version: N/A
Product Description: Outer sheaths can be combined with rigid Telescopes.
Component: N/A Open, Classified |
GCP | K790071 |
| Aug 18, 2017 | Olympus Corporation of the Americas A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W)
Product Usage:
A20975A: Working insert Terminated |
GCP | K790071 |
| Apr 19, 2017 | Olympus Corporation of the Americas High Frequency Resection Electrodes, endoscope, ac-powered and accessories
The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications. Terminated |
GCP | K790071 |
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