FGK — Tripsor, Stone, Bladder Class II
FDA product code FGK covers "Tripsor, Stone, Bladder", a Class II medical device regulated under 21 CFR 876.4500. 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
- FGK
- Device Class
- Class II
- Regulation Number
- 876.4500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K760273 | v. mueller o.v. baxter healthcare | LITHOTRITE | December 6, 1976 |