510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K131642Substantially Equivalent

Rsh Biliary Stone Removal Device

Rsh, LLC, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131642 is the FDA 510(k) clearance record for RSH BILIARY STONE REMOVAL DEVICE, a class II device, cleared for Rsh, LLC on under FDA product code LQR (Dislodger, Stone, Biliary). FDA records list one 510(k) clearance for Rsh, LLC. As of , FDA records show no recalls naming K131642.

Clearance record

Decision date
Received
(64 days to decision)
Product code
LQR Dislodger, Stone, Biliary
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Rsh, LLC 5121 Feagan St., Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LQR

Trailing 12 months
1 clearance under product code LQR in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LQR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260