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510(k) K240192

Single-use Extraction Baskets by Scivita Medical Technology Co., Ltd. — Product Code LQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2024
Date Received
January 24, 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

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  • 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)