510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K053464Substantially Equivalent

Service Manager Sm40se

Conmed Integrated Systems, Canada, ULC, Largo FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053464 is the FDA 510(k) clearance record for SERVICE MANAGER SM40SE, a class II device, cleared for Conmed Integrated Systems, Canada, Ulc on under FDA product code FYD (Apparatus, Exhaust, Surgical). FDA records list one 510(k) clearance for Conmed Integrated Systems, Canada, Ulc. As of , FDA records show no recalls naming K053464.

Clearance record

Decision date
Received
(175 days to decision)
Product code
FYD Apparatus, Exhaust, Surgical
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Conmed Integrated Systems, Canada, Ulc 11311 Concept Blvd., Largo FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FYD

Trailing 12 months

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

FDA records show no clearances under product code FYD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FYD, 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