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510(k) K912122

CHOLANGIOGRAPHY CATHETER by Wiltek Medical, Inc. — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1991
Date Received
May 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
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)
  • K910334 — ELECTROCAUTERY PROBE (February 21, 1991)
  • K894871 — WILTEK BILIARY STENT SET (December 21, 1989)

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  • K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
  • K251229 — EndoFix™Tissue Fixation System (August 20, 2025)
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  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
  • K241888 — Single-use Balloon Dilatation Catheter (December 20, 2024)