510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012822Unknown

Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model 71-Xxx

Boston Scientific Corporation, Maple Grove MN / Special, Unknown
FDA source (opens on fda.gov)

K012822 is the FDA 510(k) clearance record for MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX, a class II device, cleared for Boston Scientific Scimed, Inc. 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 K012822.

Clearance record

Decision date
Received
(62 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
Boston Scientific Scimed, Inc. One Scimed Pl., Maple Grove MN
510(k) summary
Summary
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