510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180086Substantially Equivalent

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter

Gyrus ACMI, Inc., Southborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180086 is the FDA 510(k) clearance record for Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter, a class II device, cleared for Gyrus Acmi, Inc. on under FDA product code FGE (Stents, Drains And Dilators For The Biliary Ducts). FDA records list 67 510(k) clearances for Gyrus Acmi, Inc., from to . As of , FDA records show 13 recalls naming K180086.

Clearance record

Decision date
Received
(55 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
Gyrus Acmi, Inc. 136 Tpke. Rd., Southborough MA
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