510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K933921Substantially Equivalent

Acuflex Disposable Knives

Acufex Microsurgical, Inc., Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933921 is the FDA 510(k) clearance record for ACUFLEX DISPOSABLE KNIVES, a class I device, cleared for Acufex Microsurgical, Inc. on under FDA product code HTS (Knife, Orthopedic). FDA records list 78 510(k) clearances for Acufex Microsurgical, Inc., from to . As of , FDA records show no recalls naming K933921.

Clearance record

Decision date
Received
(169 days to decision)
Product code
HTS Knife, Orthopedic
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Acufex Microsurgical, Inc. 130 Forbes Blvd., Mansfield MA
510(k) summary
Statement
Third party review
No

Clearances, product code HTS

Trailing 12 months

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

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