510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844775Substantially Equivalent

Effner-Eye Cautery with Battery Handle

Mecron Medical Products, Inc., Port Washington NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844775 is the FDA 510(k) clearance record for EFFNER-EYE CAUTERY WITH BATTERY HANDLE, a class II device, cleared for Mecron Medical Products, Inc. on under FDA product code HQO (Unit, Cautery, Thermal, Ac-Powered). FDA records list 14 510(k) clearances for Mecron Medical Products, Inc., from to . As of , FDA records show no recalls naming K844775.

Clearance record

Decision date
Received
(245 days to decision)
Product code
HQO Unit, Cautery, Thermal, Ac-Powered
Regulation
21 CFR 886.4115
Device class
Class II
Review panel
Ophthalmic
Applicant
Mecron Medical Products, Inc. 938 Port Washington Blvd., Port Washington NY
Third party review
No

Clearances, product code HQO

Trailing 12 months

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

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