Product code GBO— General, Plastic Surgery
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL
- Classification name
- Catheter, Nephrostomy, General & Plastic Surgery
- Device class
- Class 1
- Regulation
- 21 CFR 878.4200
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code GBO
FDA has cleared devices under product code GBO between 1978 and 2004, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2004
- 2002
- 1991
- 1986
- 1982
- 1979
- 1978
Top applicants under product code GBO
Adverse events under product code GBO
product code GBO- Death
- 8
- Injury
- 236
- Total
- 244
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GBO
- K041995 — MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
- K021632 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL
- K912109 — URESIL GENERAL PURPOSE DRAINAGE CATHETER
- K854905 — PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)
- K854906 — PERCUTANEOUS NEPHROSTOMY SETS (OTTO)
- K854907 — PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)
- K854909 — PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS
- K854911 — PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)
- K820867 — PERCUTANEOUS NEPHROSTOMY SET
- K781664 — SILASTIC NEPHROSTOMY SYSTEM
- K781526 — SILASTIC U-TUBE KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.