Cleared Traditional

K093653 - URESIL GASTROSTOMY CATHETER KIT

K093653 is an FDA 510(k) clearance for URESIL GASTROSTOMY CATHETER KIT, manufactured by Uresil, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K093653 · Uresil, LLC · Gastroenterology & Urology device
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Feb 2010
Decision
90d
Days
Class 2
Risk

K093653 is an FDA 510(k) clearance for the URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Uresil, LLC (Skokie, US). The FDA issued a Cleared decision on February 23, 2010 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Uresil, LLC devices

FDA 510(k) Submission Details - K093653

510(k) Number K093653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 25, 2009
Decision Date February 23, 2010
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 301
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K093653.
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
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PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
K103109 · C.R. Bard, Inc. · Dec 2010
INSTAFLO BOWEL CATHETER SYSTEM KIT
K100273 · Hollister, Inc. · Apr 2010
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
K083770 · Coloplast A/S · Nov 2009
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H
K091759 · Olympus Medical Systems Corporation · Sep 2009
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
K083153 · Hollister, Inc. · Feb 2009