510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K091139Substantially Equivalent

Conmed Aer Defense Smoke Evacuator

ConMed Corporation, Centennial CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091139 is the FDA 510(k) clearance record for CONMED AER DEFENSE SMOKE EVACUATOR, a class II device, cleared for Conmed Corporation on under FDA product code FYD (Apparatus, Exhaust, Surgical). FDA records list 84 510(k) clearances for Conmed Corporation, from to . As of , FDA records show no recalls naming K091139.

Clearance record

Decision date
Received
(15 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 Corporation 14603 E. Fremont Ave., Centennial CO
510(k) summary
Summary PDF
Third party review
Yes

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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FYD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260