Cleared Special

K041995 - MODIFICATION TO: GP GENERAL PURPOSE DRA...

K041995 is an FDA 510(k) clearance for MODIFICATION TO: GP GENERAL PURPOSE DRA..., manufactured by Uresil, LLC. 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.

K041995 · Uresil, LLC · General & Plastic Surgery device
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Aug 2004
Decision
27d
Days
Class 1
Risk

K041995 is an FDA 510(k) clearance for the MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATH.... Classified as Catheter, Nephrostomy, General & Plastic Surgery (product code GBO), Class I - General Controls.

Submitted by Uresil, LLC (Skokie, US). The FDA issued a Cleared decision on August 19, 2004 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, LLC devices

FDA 510(k) Submission Details - K041995

510(k) Number K041995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2004
Decision Date August 19, 2004
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

Devices cleared under the same product code (GBO) and FDA review panel - the closest regulatory comparables to K041995.
URESIL GENERAL PURPOSE DRAINAGE CATHETER
K912109 · Uresil Corp. · Aug 1991
PERCUTANEOUS NEPHROSTOMY SET
K820867 · Van-Tec, Inc. · Apr 1982
SILASTIC NEPHROSTOMY SYSTEM
K781664 · Dow Corning Corp. Healthcare Industries Materials · Jan 1979
SILASTIC U-TUBE KIT
K781526 · Dow Corning Corp. Healthcare Industries Materials · Sep 1978