Cleared Special

MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY (K041995) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

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

Submission Details

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.

Device Classification

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.