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510(k) K243807

Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P by Olympus Medical Systems Corp. — Product Code LQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2025
Date Received
December 11, 2024
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

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Other clearances for product code LQR

  • 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)
  • K171915 — Nathanson Transcystic Bile Duct Stone Exploration Pack (March 1, 2018)
  • K173687 — Strange Bile Duct Stone Exploration Set (December 15, 2017)