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510(k) K131642

RSH BILIARY STONE REMOVAL DEVICE by Rsh, LLC — Product Code LQR

K131642 is an FDA 510(k) premarket notification submitted by Rsh, LLC for the device "RSH BILIARY STONE REMOVAL DEVICE". The FDA issued a decision of Substantially Equivalent on August 7, 2013. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2013
Date Received
June 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Biliary
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances for product code LQR

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  • K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P (March 18, 2025)
  • K243471 — Extraction Basket (December 16, 2024)
  • K240192 — Single-use Extraction Baskets (October 15, 2024)
  • K230598 — Stone Extraction Baskets (September 12, 2023)
  • K203322 — SpyGlass Discover Retrieval Basket (May 26, 2021)
  • K201509 — Disposable Stone Extraction basket (December 16, 2020)
  • K191789 — Stonetome Stone Removal Device (July 25, 2019)
  • K182381 — Wilson-Cook Mini Basket (October 30, 2018)
  • K171969 — Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Mem (March 28, 2018)

FDA data resources