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510(k) K230598

Stone Extraction Baskets by Jiangsu Vedkang Medical Science and Technology Co., Ltd. — Product Code LQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2023
Date Received
March 3, 2023
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 by Jiangsu Vedkang Medical Science and Technology Co., Ltd.

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  • K232752 — Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23 (February 26, 2024)
  • K232245 — VedDilator ^TM (3-Stage Balloon Dilation Catheter) (February 15, 2024)
  • K222146 — Disposable Endoscopic Hemoclip (March 28, 2023)
  • K220089 — Disposable Polyp Snare (September 22, 2022)
  • K213914 — Injection Needle (July 29, 2022)

Other clearances for product code LQR

  • 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)
  • 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)