Atlas FDA

GBO

11 FDA 510(k) clearances · Product code

46 daysmedian time to decision
91 days90th percentile
11clearances measured

FDA profile

Official device name
Catheter, Nephrostomy, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2020: 127 · 2021: 115 · 2022: 121 · 2023: 145 · 2024: 32 · 2025: 71
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY (K041995)Uresil, LLC2004-08-19
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C (K021632)Uresil, L.P.2002-06-13
URESIL GENERAL PURPOSE DRAINAGE CATHETER (K912109)Uresil Corp.1991-08-12
PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) (K854911)Angiomed U.S., Inc.1986-01-24
PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS (K854909)Angiomed U.S., Inc.1986-01-24
PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) (K854905)Angiomed U.S., Inc.1986-01-24
PERCUTANEOUS NEPHROSTOMY SETS (OTTO) (K854906)Angiomed U.S., Inc.1986-01-24
PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) (K854907)Angiomed U.S., Inc.1986-01-24
PERCUTANEOUS NEPHROSTOMY SET (K820867)Van-Tec, Inc.1982-04-13
SILASTIC NEPHROSTOMY SYSTEM (K781664)Dow Corning Corp. Healthcare Industries Materials1979-01-22
SILASTIC U-TUBE KIT (K781526)Dow Corning Corp. Healthcare Industries Materials1978-09-20

Track GBO automatically

Every clearance here is in the API, with alerts when new ones post.