510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980492Substantially Equivalent

Aeh-3 Electrohydraulic Lithotripter and Probes (E-1F, E-3F, E-5F, and E-9F)

Circon Acmi, Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980492 is the FDA 510(k) clearance record for AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F), a class II device, cleared for Circon Acmi on under FDA product code FFK (Lithotriptor, Electro-Hydraulic). FDA records list 10 510(k) clearances for Circon Acmi, from to . As of , FDA records show 4 recalls naming K980492.

Clearance record

Decision date
Received
(281 days to decision)
Product code
FFK Lithotriptor, Electro-Hydraulic
Regulation
21 CFR 876.4480
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Circon Acmi 300 Stillwater Ave., Stamford CT
510(k) summary
Summary
Third party review
No

Clearances, product code FFK

Trailing 12 months

FDA records hold no clearances under product code FFK in the trailing twelve months.

FDA records show no clearances under product code FFK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260