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510(k) K894865

WILTEK BALLOON STONE EXTRACTOR by Wiltek Medical, Inc. — Product Code LQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1989
Date Received
July 31, 1989
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 Wiltek Medical, Inc.

  • K990231 — WILTEK HOT BIOPSY FORCEPS (April 13, 1999)
  • K922989 — WILTEK IRRIGAITON/ASPIRATION TUBE SET (February 15, 1994)
  • K930419 — WILTEK BIOPSY FORCEPS (June 1, 1993)
  • K914881 — WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (January 7, 1992)
  • K914882 — WILTEK BALLOON CHOLANGIOGRAPHY CATHETER (January 7, 1992)
  • K914132 — WILTEK ELECTROCAUTERY ACTIVE CORD (September 25, 1991)
  • K914131 — WILTEK ELECTROCAUTERY ADAPTOR (September 25, 1991)
  • K912288 — WILTEK STANDARD CHOLANGIOGRAPHY CATHETER (September 23, 1991)
  • K912122 — CHOLANGIOGRAPHY CATHETER (September 23, 1991)
  • K910334 — ELECTROCAUTERY PROBE (February 21, 1991)

Other clearances for product code LQR

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  • 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)