Cleared Special

K021632 - GP GENERAL PURPOSE DRAINAGE CATHETER

Also marketed or referenced as:
MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL GP GENERAL PURPOSE DRAINAGE C

K021632 is an FDA 510(k) clearance for GP GENERAL PURPOSE DRAINAGE CATHETER, manufactured by Uresil, L.P.. The device is a Class 1 General & Plastic Surgery device with product code GBO cleared through the Special 510(k) pathway after a 27-day FDA review.

K021632 · Uresil, L.P. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
27d
Days
Class 1
Risk

K021632 is an FDA 510(k) clearance for the GP GENERAL PURPOSE DRAINAGE CATHETER. Classified as Catheter, Nephrostomy, General & Plastic Surgery (product code GBO), Class I - General Controls.

Submitted by Uresil, L.P. (Skokie, US). The FDA issued a Cleared decision on June 13, 2002 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Uresil, L.P. devices

FDA 510(k) Submission Details - K021632

510(k) Number K021632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2002
Decision Date June 13, 2002
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

GBO Device Classification - Class 1, General Controls

Product Code GBO Catheter, Nephrostomy, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBO Catheter, Nephrostomy, General & Plastic Surgery

All 9
Devices cleared under the same product code (GBO) and FDA review panel - the closest regulatory comparables to K021632.
URESIL GENERAL PURPOSE DRAINAGE CATHETER
K912109 · Uresil Corp. · Aug 1991
PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)
K854905 · Angiomed U.S., Inc. · Jan 1986
PERCUTANEOUS NEPHROSTOMY SETS (OTTO)
K854906 · Angiomed U.S., Inc. · Jan 1986
PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)
K854907 · Angiomed U.S., Inc. · Jan 1986
PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS
K854909 · Angiomed U.S., Inc. · Jan 1986
PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)
K854911 · Angiomed U.S., Inc. · Jan 1986