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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K882654Substantially Equivalent

Physiotron(tm) Microsurgical Motor & Cooling Sys.

Surgical Innovators of America, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882654 is the FDA 510(k) clearance record for PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS., a class I device, cleared for Surgical Innovators of America, Inc. on under FDA product code GEY (Motor, Surgical Instrument, Ac-Powered). FDA records list one 510(k) clearance for Surgical Innovators of America, Inc. As of , FDA records show no recalls naming K882654.

Clearance record

Decision date
Received
(83 days to decision)
Product code
GEY Motor, Surgical Instrument, Ac-Powered
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Surgical Innovators of America, Inc. 19 W. 34th St., Suite 301, New York NY
Third party review
No

Clearances, product code GEY

Trailing 12 months

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

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