FBX — Sound, Urethral, Metal Or Plastic Class I
FDA product code FBX covers "Sound, Urethral, Metal Or Plastic", a Class I medical device regulated under 21 CFR 876.5520. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- FBX
- Device Class
- Class I
- Regulation Number
- 876.5520
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K950633 | candela laser | CANDELA URETHRAL/BLADDER SOUND | March 6, 1995 |