FDA product code FAH: Dilator, Urethral, Mechanical
FAH is the FDA product code for dilator, urethral, mechanical. It is a Class II device, regulated under 21 CFR 876.5520 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under FAH, from 3 different applicants. The average 510(k) review took 89 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Urethral, Mechanical |
| Device class | Class II |
| Regulation | 21 CFR 876.5520 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FAH clearance
Top FAH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 2 | 1990-08-17 |
| Cook Urological, Inc. | 1 | 1993-11-17 |
| Thomas J. Fogarty, M.D. | 1 | 1983-07-26 |
Most recent FAH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933957 | Cook Urological, Inc. | DILATING URETHRAL SOUND | 1993-11-17 | 97 |
| K902370 | Boston Scientific Corp | MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER | 1990-08-17 | 80 |
| K902124 | Boston Scientific Corp | DOWD CATHETER | 1990-08-09 | 90 |
| K831384 | Thomas J. Fogarty, M.D. | COAXIAL BALLOON URETHRAL DILATOR | 1983-07-26 | 89 |
Recalls for FAH devices
openFDA lists no recalls for product code FAH.
Frequently asked questions
What is FDA product code FAH?
FAH is the FDA product code for dilator, urethral, mechanical. It is a Class II device, regulated under 21 CFR 876.5520 and reviewed by the Gastroenterology and Urology panel.
What device class is FAH?
Class II, regulation 21 CFR 876.5520. Typical premarket route: 510(k).
How long does a 510(k) take for product code FAH?
Across 4 cleared submissions the average was 89 days from receipt to decision (median 90).
Which companies have the most FAH clearances?
Boston Scientific Corp (2); Cook Urological, Inc. (1); Thomas J. Fogarty, M.D. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FAH
- Run a recall and safety report across every FAH manufacturer
- Watch product code FAH 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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