Panels › Gastroenterology, Urology › Product code FDC · Class 2
Resectoscope, Working Element
Regulation 876.1500
0510(k)s in 12 months (11 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FDC
| Company | 510(k)s | Recalls |
|---|---|---|
| V. Mueller O.V. Baxter Healthcare Corp. | 3 | 0 |
| Gm Engineering, Inc. | 2 | 0 |
| Orthoconcept, Inc. | 2 | 0 |
| Acmi-Circon Corporation | 1 | 0 |
| Laser Industries , Ltd. | 1 | 0 |
| Mahe Intl., Inc. | 1 | 0 |
| Olympus Winter & Ibe GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 9, 2002 | K021166 | ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR Acmi-Circon Corporation | FDC |
| Sep 29, 1999 | K992141 | OLYMPUS WORKING ELEMENT FOR PROBES Olympus Winter & Ibe GmbH | FDC |
| Aug 5, 1999 | K991426 | MAHE INSTRUMENTS Mahe Intl., Inc. | FDC |
| May 30, 1995 | K942626 | CONTINUOUS FLOW BIOPSY PROBE Gm Engineering, Inc. | FDC |
| Feb 25, 1994 | K933962 | GM CONTINUOUS FLOW BIOPSY PROBE Gm Engineering, Inc. | FDC |
| Oct 17, 1989 | K895643 | MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM Orthoconcept, Inc. | FDC |
| Aug 11, 1989 | K894363 | UROPUMP* FLUID MANAGEMENT SYSTEM Orthoconcept, Inc. | FDC |
| Aug 27, 1984 | K842997 | LASER RECTOSCOPE SET 784 Laser Industries , Ltd. | FDC |
| Dec 2, 1976 | K760184 | ELEMENT, WORKING V. Mueller O.V. Baxter Healthcare Corp. | FDC |
| Dec 2, 1976 | K760182 | SHEATH, RESECTOSCOPE V. Mueller O.V. Baxter Healthcare Corp. | FDC |
| Aug 30, 1976 | K760174 | ADAPTER, RESECTOSCOPE V. Mueller O.V. Baxter Healthcare Corp. | FDC |
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