Bougie, Urological
The Urological Bougie (product code FAX) is a slender, flexible or semi-rigid dilating instrument used to progressively enlarge the urethral lumen in the management of urethral strictures. It is an FDA Class 1 device (lowest risk), subject to general controls only with no premarket notification required. It is regulated under 21 CFR 876.5520 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- FAX
- Device Class
- FDA class 1
- Regulation Number
- 876.5520
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.