FDA product code FEC: Obturator, For Endoscope
FEC is the FDA product code for obturator, for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FEC, from 2 different applicants. The average 510(k) review took 127 days (median 149).
Classification
| Field | Value |
|---|---|
| Device name | Obturator, For Endoscope |
| 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 FEC clearance
Top FEC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| V. Mueller O.V. Baxter Healthcare Corp. | 2 | 1976-12-02 |
| Novasys Medical, Inc. | 1 | 2000-07-17 |
Most recent FEC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001328 | Novasys Medical, Inc. | INTRODUCER SHEATH | 2000-07-17 | 82 |
| K760183 | V. Mueller O.V. Baxter Healthcare Corp. | OBTURATOR, DEFLECTING | 1976-12-02 | 149 |
| K760172 | V. Mueller O.V. Baxter Healthcare Corp. | OBTURATOR, VISUAL | 1976-12-02 | 149 |
Recalls for FEC devices
openFDA lists no recalls for product code FEC.
Frequently asked questions
What is FDA product code FEC?
FEC is the FDA product code for obturator, for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FEC?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FEC?
Across 3 cleared submissions the average was 127 days from receipt to decision (median 149).
Which companies have the most FEC clearances?
V. Mueller O.V. Baxter Healthcare Corp. (2); Novasys Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FEC
- Run a recall and safety report across every FEC manufacturer
- Watch product code FEC 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times