Cleared Traditional

K915506 - LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT

K915506 is an FDA 510(k) clearance for LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCA cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K915506 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Mar 1992
Decision
88d
Days
Class 2
Risk

K915506 is an FDA 510(k) clearance for the LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT. Classified as Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 6, 1992 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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

FDA 510(k) Submission Details - K915506

510(k) Number K915506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 09, 1991
Decision Date March 06, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 131d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCA Device Classification - Class 2, Special Controls

Product Code GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

All 22
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K915506.
BARD STONE REMOVAL BALLOON CATHETER
K920342 · C.R. Bard, Inc. · Aug 1992
URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K915343 · Uresil Corp. · Mar 1992
DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
K914755 · Davol, Inc. · Mar 1992
LAPAROSCOPIC CHOLANGIOCATH
K911487 · United States Endoscopy Group, Inc. · Aug 1991
INTIMAX(TM) IRRIGATION CATHETER
K911181 · Applied Vascular Devices, Inc. · Apr 1991
T-TUBE WHELAN-MOSS
K772292 · Davol, Inc. · Dec 1977