Cleared Traditional

K911477 - LAPAROSCOPIC BASKET FLEXIBLE AND RIGID

K911477 is the FDA 510(k) clearance for LAPAROSCOPIC BASKET FLEXIBLE AND RIGID by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LQC) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K911477 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Aug 1991
Decision
132d
Days
Class 2
Risk

K911477 is an FDA 510(k) clearance for the LAPAROSCOPIC BASKET FLEXIBLE AND RIGID. Classified as Lithotriptor, Biliary Mechanical (product code LQC), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on August 14, 1991 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4500 - 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 United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K911477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date August 14, 1991
Days to Decision 132 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 130d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LQC Lithotriptor, Biliary Mechanical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4500
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 - LQC Lithotriptor, Biliary Mechanical

All 8
Devices cleared under the same product code (LQC) and FDA review panel - the closest regulatory comparables to K911477.
MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR
K943191 · Boston Scientific Corp · Aug 1994
LAPAROLITH
K905552 · Baxter Healthcare Corp · Dec 1991
SPOON FORCEPS, 11MM
K911364 · Northgate Technologies, Inc. · Oct 1991
BML SERIES
K903529 · Olympus Corp. · Jan 1991
SOEHENDRA LITHOTRIPSY SET
K902170 · Wilson-Cook Medical, Inc. · Jul 1990