Resectoscope, Working Element
FDA product code FDC · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
11510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021166 | Acmi Bipolar Rectoscope, Model Eiwe-BrFDC · Special | Acmi-Circon Corporation | 05/09/2002SE |
| K992141 | Olympus Working Element for ProbesFDC · Traditional | Olympus Winter & Ibe GmbH | 09/29/1999SE |
| K991426 | Mahe InstrumentsFDC · Traditional | Mahe Intl., Inc. | 08/05/1999SE |
| K942626 | Continuous Flow Biopsy ProbeFDC · Traditional | Gm Engineering, Inc. | 05/30/1995SE |
| K933962 | GM Continuous Flow Biopsy ProbeFDC · Traditional | Gm Engineering, Inc. | 02/25/1994SE |
| K895643 | Modified Uropump* Fluid Management SystemFDC · Traditional | Orthoconcept, Inc. | 10/17/1989SE |
| K894363 | Uropump* Fluid Management SystemFDC · Traditional | Orthoconcept, Inc. | 08/11/1989SE |
| K842997 | Laser Rectoscope Set 784FDC · Traditional | Laser Industries , Ltd. | 08/27/1984SE |
| K760184 | Element, WorkingFDC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 12/02/1976SE |
| K760182 | Sheath, ResectoscopeFDC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 12/02/1976SE |
| K760174 | Adapter, ResectoscopeFDC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 08/30/1976SE |