510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053404Unknown

Lifestent Flexstart Biliary Stent System

Edwards Lifesciences LLC, Irvine CA / Special, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053404 is the FDA 510(k) clearance record for LIFESTENT FLEXSTART BILIARY STENT SYSTEM, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code FGE (Stents, Drains And Dilators For The Biliary Ducts). FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show 103 recalls naming K053404.

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
Edwards Lifesciences, LLC One Edwards Way, Irvine CA
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