FDA product code FDC: Resectoscope, Working Element
FDC is the FDA product code for resectoscope, working element. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 11 510(k) submissions under FDC, from 7 different applicants. The average 510(k) review took 113 days (median 97).
Classification
| Field | Value |
|---|---|
| Device name | Resectoscope, Working Element |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every FDC clearance
Top FDC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| V. Mueller O.V. Baxter Healthcare Corp. | 3 | 1976-12-02 |
| Gm Engineering, Inc. | 2 | 1995-05-30 |
| Orthoconcept, Inc. | 2 | 1989-10-17 |
| Acmi-Circon Corporation | 1 | 2002-05-09 |
| Olympus Winter & Ibe GmbH | 1 | 1999-09-29 |
2 more applicants have FDC clearances. See the full list in Caduvo.
Most recent FDC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K021166 | Acmi-Circon Corporation | ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR | 2002-05-09 | 28 |
| K992141 | Olympus Winter & Ibe GmbH | OLYMPUS WORKING ELEMENT FOR PROBES | 1999-09-29 | 97 |
| K991426 | Mahe Intl., Inc. | MAHE INSTRUMENTS | 1999-08-05 | 104 |
| K942626 | Gm Engineering, Inc. | CONTINUOUS FLOW BIOPSY PROBE | 1995-05-30 | 362 |
| K933962 | Gm Engineering, Inc. | GM CONTINUOUS FLOW BIOPSY PROBE | 1994-02-25 | 196 |
Recalls for FDC devices
openFDA lists no recalls for product code FDC.
Frequently asked questions
What is FDA product code FDC?
FDC is the FDA product code for resectoscope, working element. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FDC?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FDC?
Across 11 cleared submissions the average was 113 days from receipt to decision (median 97).
Which companies have the most FDC clearances?
V. Mueller O.V. Baxter Healthcare Corp. (3); Gm Engineering, Inc. (2); Orthoconcept, Inc. (2); Acmi-Circon Corporation (1); Olympus Winter & Ibe GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FDC
- Run a recall and safety report across every FDC manufacturer
- Watch product code FDC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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