FDA product code FAX: Bougie, Urological
FAX is the FDA product code for bougie, urological. It is a Class I device, regulated under 21 CFR 876.5520 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FAX, from 2 different applicants. The average 510(k) review took 42 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Bougie, Urological |
| Device class | Class I |
| Regulation | 21 CFR 876.5520 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FAX clearance
Top FAX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 1 | 1995-02-07 |
| Parker Laboratories, Inc. | 1 | 1982-11-03 |
Most recent FAX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950125 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ BOUGIES AND DILATORS | 1995-02-07 | 26 |
| K822711 | Parker Laboratories, Inc. | ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL | 1982-11-03 | 57 |
Recalls for FAX devices
openFDA lists no recalls for product code FAX.
Frequently asked questions
What is FDA product code FAX?
FAX is the FDA product code for bougie, urological. It is a Class I device, regulated under 21 CFR 876.5520 and reviewed by the Gastroenterology and Urology panel.
What device class is FAX?
Class I, regulation 21 CFR 876.5520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FAX?
Across 2 cleared submissions the average was 42 days from receipt to decision (median 42).
Which companies have the most FAX clearances?
KARL STORZ Endoscopy-America, Inc. (1); Parker Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FAX
- Run a recall and safety report across every FAX manufacturer
- Watch product code FAX 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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