Cleared Traditional

K834350 - ACUFEX DREZ COMMUNICATING DRILL GUIDE

K834350 is an FDA 510(k) clearance for ACUFEX DREZ COMMUNICATING DRILL GUIDE, manufactured by Acufex Microsurgical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FZX cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K834350 · Acufex Microsurgical, Inc. · General & Plastic Surgery device
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Mar 1984
Decision
97d
Days
Class 1
Risk

K834350 is an FDA 510(k) clearance for the ACUFEX DREZ COMMUNICATING DRILL GUIDE. Classified as Guide, Surgical, Instrument (product code FZX), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Acufex Microsurgical, Inc. devices

FDA 510(k) Submission Details - K834350

510(k) Number K834350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1983
Decision Date March 19, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

FZX Device Classification - Class 1, General Controls

Product Code FZX Guide, Surgical, Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FZX Guide, Surgical, Instrument

All 12
Devices cleared under the same product code (FZX) and FDA review panel - the closest regulatory comparables to K834350.
NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
K852402 · North American Instrument Corp. · Jul 1985
BRITISH SPINAL FUSION SET
K842698 · Downs Surgical , Ltd. · Sep 1984
TECHMEDICA DRILL GUIDE
K841297 · Techmedica, Inc. · Apr 1984
GRAF MENISCAL SUTURE SET
K830720 · Acufex Microsurgical, Inc. · Jun 1983
DISPOSABLE NEEDLE HOLDERS
K821618 · Medcare Products · Jun 1982
BOUNDARY TUBING HOLDERS
K810888 · The Buckeye Cellulose Corp. · Apr 1981