510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043481Unknown

Modification to: Zilver 635 Biliary Stent

Cook Inc., Bloomington IN / Special, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043481 is the FDA 510(k) clearance record for MODIFICATION TO: ZILVER 635 BILIARY STENT, a class II device, cleared for Cook, Inc. on under FDA product code FGE (Stents, Drains And Dilators For The Biliary Ducts). FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show 28 recalls naming K043481.

Clearance record

Decision date
Received
(14 days to decision)
Product code
FGE Stents, Drains And Dilators For The Biliary Ducts
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cook, Inc. 750 Daniels Way, Bloomington IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FGE

Trailing 12 months
10 clearances under product code FGE in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FGE, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20262
April 20262
May 20260
June 20261
July 20261
August 20260
September 20262
October 20260