510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844774Substantially Equivalent

Effner Fiber Optic Cables for Cold Light Transmiss

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

K844774 is the FDA 510(k) clearance record for EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS, a class II device, cleared for Mecron Medical Products, Inc. on under FDA product code FCR (Light Source, Photographic, Fiberoptic). FDA records list 14 510(k) clearances for Mecron Medical Products, Inc., from to . As of , FDA records show no recalls naming K844774.

Clearance record

Decision date
Received
(133 days to decision)
Product code
FCR Light Source, Photographic, Fiberoptic
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mecron Medical Products, Inc. 938 Port Washington Blvd., Port Washington NY
Third party review
No

Clearances, product code FCR

Trailing 12 months

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

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