Cleared Traditional

K960177 - P.E.G. PATIENT CARE KIT

K960177 is the FDA 510(k) clearance for P.E.G. PATIENT CARE KIT 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 73-day FDA review.

K960177 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
73d
Days
Class 2
Risk

K960177 is an FDA 510(k) clearance for the P.E.G. PATIENT CARE KIT. 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 March 29, 1996 after a review of 73 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K960177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date March 29, 1996
Days to Decision 73 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
57d faster than avg
Panel avg: 130d · This submission: 73d
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 K960177.
KANGAROO FEEDING TUBE PLACMENT STYLET
K960632 · Sherwood Medical Co. · May 1996
WILSON-COOK BALLOON INFLATION DEVICE
K960415 · Wilson-Cook Medical, Inc. · Apr 1996
PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION)
K954879 · United States Endoscopy Group, Inc. · Mar 1996
KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT
K954429 · Sherwood Medical Co. · Mar 1996
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