510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K972225Substantially Equivalent

Ufr Fiberoptic Cable

Universal Fiberoptic Repair, Inc., Pomfret Center CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972225 is the FDA 510(k) clearance record for UFR FIBEROPTIC CABLE, a class II device, cleared for Universal Fiberoptic Repair, Inc. on under FDA product code FST (Light, Surgical, Fiberoptic). FDA records list one 510(k) clearance for Universal Fiberoptic Repair, Inc. As of , FDA records show no recalls naming K972225.

Clearance record

Decision date
Received
(278 days to decision)
Product code
FST Light, Surgical, Fiberoptic
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Universal Fiberoptic Repair, Inc. 9 Wrights Crossing, Pomfret Center CT
510(k) summary
Statement
Third party review
No

Clearances, product code FST

Trailing 12 months

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

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