FDA product code FEX: Instrument, Catheter, Punch
FEX is the FDA product code for instrument, catheter, punch. It is a Class I device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FEX, from 2 different applicants. The average 510(k) review took 52 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Catheter, Punch |
| Device class | Class I |
| Regulation | 21 CFR 876.5090 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FEX clearance
Top FEX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hgm Medical Laser Systems, Inc. | 1 | 1991-06-11 |
| Xomed, Inc. | 1 | 1977-09-26 |
Most recent FEX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911104 | Hgm Medical Laser Systems, Inc. | PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 | 1991-06-11 | 90 |
| K771725 | Xomed, Inc. | BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. | 1977-09-26 | 13 |
Recalls for FEX devices
openFDA lists no recalls for product code FEX.
Frequently asked questions
What is FDA product code FEX?
FEX is the FDA product code for instrument, catheter, punch. It is a Class I device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel.
What device class is FEX?
Class I, regulation 21 CFR 876.5090. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FEX?
Across 2 cleared submissions the average was 52 days from receipt to decision (median 52).
Which companies have the most FEX clearances?
Hgm Medical Laser Systems, Inc. (1); Xomed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FEX
- Run a recall and safety report across every FEX manufacturer
- Watch product code FEX 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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