510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K834350Substantially Equivalent

Acufex Drez Communicating Drill Guide

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

K834350 is the FDA 510(k) clearance record for ACUFEX DREZ COMMUNICATING DRILL GUIDE, a class I device, cleared for Acufex Microsurgical, Inc. on under FDA product code FZX (Guide, Surgical, Instrument). FDA records list 78 510(k) clearances for Acufex Microsurgical, Inc., from to . As of , FDA records show no recalls naming K834350.

Clearance record

Decision date
Received
(97 days to decision)
Product code
FZX Guide, Surgical, Instrument
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Acufex Microsurgical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FZX

Trailing 12 months

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

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