Dilator, Urethral, Mechanical
The Mechanical Urethral Dilator (product code FAH) is an instrument used to progressively dilate the urethral lumen in order to treat urethral strictures or to facilitate catheter insertion. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.5520 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.
Research product code FAH in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- FAH
- Device Class
- FDA class 2
- Regulation Number
- 876.5520
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933957 | DILATING URETHRAL SOUND | Nov 17, 1993 | Substantially Equivalent | Cook Urological, Inc. |
| K902370 | MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER | Aug 17, 1990 | Substantially Equivalent | Boston Scientific Corp |
| K902124 | DOWD CATHETER | Aug 09, 1990 | Substantially Equivalent | Boston Scientific Corp |
| K831384 | COAXIAL BALLOON URETHRAL DILATOR | Jul 26, 1983 | Substantially Equivalent | Thomas J. Fogarty, M.D. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.