FDC
11 FDA 510(k) clearances · Product code
97 daysmedian time to decision
196 days90th percentile
11clearances measured
FDA profile
- Official device name
- Resectoscope, Working Element
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2013: 21 · 2014: 29 · 2015: 12 · 2019: 14 · 2025: 21 · 2026: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR (K021166) | Acmi-Circon Corporation | 2002-05-09 |
| OLYMPUS WORKING ELEMENT FOR PROBES (K992141) | Olympus Winter & Ibe GmbH | 1999-09-29 |
| MAHE INSTRUMENTS (K991426) | Mahe Intl., Inc. | 1999-08-05 |
| CONTINUOUS FLOW BIOPSY PROBE (K942626) | Gm Engineering, Inc. | 1995-05-30 |
| GM CONTINUOUS FLOW BIOPSY PROBE (K933962) | Gm Engineering, Inc. | 1994-02-25 |
| MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM (K895643) | Orthoconcept, Inc. | 1989-10-17 |
| UROPUMP* FLUID MANAGEMENT SYSTEM (K894363) | Orthoconcept, Inc. | 1989-08-11 |
| LASER RECTOSCOPE SET 784 (K842997) | Laser Industries , Ltd. | 1984-08-27 |
| ELEMENT, WORKING (K760184) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
| SHEATH, RESECTOSCOPE (K760182) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
| ADAPTER, RESECTOSCOPE (K760174) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-08-30 |
Track FDC automatically
Every clearance here is in the API, with alerts when new ones post.