Cleared Traditional

K834350 - ACUFEX DREZ COMMUNICATING DRILL GUIDE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 114d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.