Cleared Traditional

K924306 - PERCUTANEOUS ENDOSCOPIC GASTROSTOMY

K924306 is the FDA 510(k) clearance for PERCUTANEOUS ENDOSCOPIC GASTROSTOMY by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 992-day FDA review.

K924306 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
992d
Days
Class 2
Risk

K924306 is an FDA 510(k) clearance for the PERCUTANEOUS ENDOSCOPIC GASTROSTOMY. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 992 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K924306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1992
Decision Date May 15, 1995
Days to Decision 992 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
862d slower than avg
Panel avg: 130d · This submission: 992d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 218
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K924306.
REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY
K954776 · United States Endoscopy Group, Inc. · Jan 1996
BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES
K946249 · C.R. Bard, Inc. · Dec 1995
HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE
K953232 · Hollister, Inc. · Aug 1995
FLEXIFLO SIX ENTERAL NUTRITION PUMP SET
K943240 · Abbott Laboratories · Apr 1995
FLEXIFLO NASOENTERIC FEEDING TUBE
K922217 · Abbott Laboratories · Mar 1995
FLEXIFLO TUBE PLACEMENT VERIFIER
K922216 · Abbott Laboratories · Jan 1995