Cleared Traditional

K131642 - RSH BILIARY STONE REMOVAL DEVICE

K131642 is an FDA 510(k) clearance for RSH BILIARY STONE REMOVAL DEVICE, manufactured by Rsh, LLC. The device is a Class 2 Gastroenterology & Urology device with product code LQR cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K131642 · Rsh, LLC · Gastroenterology & Urology device
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Aug 2013
Decision
64d
Days
Class 2
Risk

K131642 is an FDA 510(k) clearance for the RSH BILIARY STONE REMOVAL DEVICE. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Rsh, LLC (Houston, US). The FDA issued a Cleared decision on August 7, 2013 after a review of 64 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 Rsh, LLC devices

FDA 510(k) Submission Details - K131642

510(k) Number K131642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2013
Decision Date August 07, 2013
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQR Device Classification - Class 2, Special Controls

Product Code LQR Dislodger, Stone, Biliary
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 - LQR Dislodger, Stone, Biliary

All 26
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K131642.
Wittich Nitinol Stone Basket
K170898 · Cook Incorporated · Dec 2017
Single Use Retrieval Nitinol Basket V
K170811 · Olympus Medical Systems Corp. · Nov 2017
NCompass Nitinol Stone Extractors
K173009 · Cook Incorporated · Nov 2017
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A
K091495 · Olympus Medical Systems Corporation · Sep 2009
SPYCATCH STONE RETRIEVAL BASKET
K071066 · Boston Scientific Corp · Jun 2007
KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS
K952149 · KARL STORZ Endoscopy-America, Inc. · Jun 1995