Panels › Gastroenterology, Urology › Product code FER · Class 2
Anoscope And Accessories
Regulation 876.1500
0510(k)s in 12 months (27 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in FER
| Company | 510(k)s | Recalls |
|---|---|---|
| Applied Medical Resources | 4 | 1 |
| Thd Spa | 5 | 0 |
| Sightline Technologies , Ltd. | 2 | 0 |
| Welch Allyn, Inc. | 2 | 0 |
| Angiologica B. M. Srl | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Canadian Theatre Products , Ltd. | 1 | 0 |
| Cook Ireland, Ltd. | 1 | 0 |
| Dispos-A-Scope | 1 | 0 |
| Ethicon Endo-Surgery, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2018 | Applied Medical Resources Corp GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm
REF TA211
Product Usage: The GelPOINT Path Transanal Access Platform is indicat Terminated |
FER | K171701 |
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