NGU — Balloon, Liver Tamponade Class II
FDA product code NGU covers "Balloon, Liver Tamponade", a Class II medical device regulated under 21 CFR 876.5980. 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
- NGU
- Device Class
- Class II
- Regulation Number
- 876.5980
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K010450 | cook | LIVER TAMPONADE BALLOON | September 6, 2001 |