510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K934172Substantially Equivalent

Acro-Poly, Inc. Handpiece/anglehead Accessories for Surgical Instuments

Acro-Poly, Inc., Riverside CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934172 is the FDA 510(k) clearance record for ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS, a class I device, cleared for Acro-Poly, Inc. on under FDA product code GEY (Motor, Surgical Instrument, Ac-Powered). FDA records list one 510(k) clearance for Acro-Poly, Inc. As of , FDA records show no recalls naming K934172.

Clearance record

Decision date
Received
(61 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
Acro-Poly, Inc. 12155 Magnolia Ave., Riverside CA
510(k) summary
Statement
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