Cleared Traditional

K911477 - LAPAROSCOPIC BASKET FLEXIBLE AND RIGID

K911477 is an FDA 510(k) clearance for LAPAROSCOPIC BASKET FLEXIBLE AND RIGID, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K911477

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
1d slower than avg
Panel avg: 131d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQC Device Classification - Class 2, Special Controls

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 9
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