510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K053454Unknown

Rx Herculink Elite Biliary Stent System

Boston Scientific Corporation, Santa Clara CA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053454 is the FDA 510(k) clearance record for RX HERCULINK ELITE BILIARY STENT SYSTEM, a class II device, cleared for Guidant Corporation on under FDA product code FGE (Stents, Drains And Dilators For The Biliary Ducts). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K053454.

Clearance record

Decision date
Received
(87 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
Guidant Corporation 3200 Lakeside Dr., Santa Clara 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 November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FGE, trailing twelve months
MonthClearances
December 20252
January 20260
February 20260
March 20262
April 20262
May 20260
June 20261
July 20261
August 20260
September 20262
October 20260
November 20260