GBO — Catheter, Nephrostomy, General & Plastic Surgery Class I
FDA product code GBO covers "Catheter, Nephrostomy, General & Plastic Surgery", a Class I medical device regulated under 21 CFR 878.4200. Submissions are reviewed by the General, Plastic Surgery panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GBO
- Device Class
- Class I
- Regulation Number
- 878.4200
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K041995 | uresil | MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETE | August 19, 2004 |
| K021632 | uresil, l.p | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKIN | June 13, 2002 |
| K912109 | uresil | URESIL GENERAL PURPOSE DRAINAGE CATHETER | August 12, 1991 |
| K854911 | angiomed u.s | PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) | January 24, 1986 |
| K854905 | angiomed u.s | PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) | January 24, 1986 |
| K854907 | angiomed u.s | PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) | January 24, 1986 |
| K854906 | angiomed u.s | PERCUTANEOUS NEPHROSTOMY SETS (OTTO) | January 24, 1986 |
| K854909 | angiomed u.s | PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS | January 24, 1986 |
| K820867 | van-tec | PERCUTANEOUS NEPHROSTOMY SET | April 13, 1982 |
| K781664 | dow corning corp. healthcare industries materials | SILASTIC NEPHROSTOMY SYSTEM | January 22, 1979 |
| K781526 | dow corning corp. healthcare industries materials | SILASTIC U-TUBE KIT | September 20, 1978 |