Sound, Urethral, Metal Or Plastic
The Urethral Sound (Metal or Plastic) (product code FBX) is a probe-shaped instrument used to explore, calibrate, or dilate the urethra in urological diagnosis and treatment. It is an FDA Class 1 device (lowest risk), subject only to general controls 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
- FBX
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950633 | CANDELA URETHRAL/BLADDER SOUND | Mar 06, 1995 | Substantially Equivalent | Candela Laser Corp. |
FEI Numbers
This FDA classification entry is associated with 54 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 54 registration numbers. Click on an entry to view related FDA registrations.