Cleared Traditional

K884565 - ACUFEX FIXATION BUTTON (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K884565 · Acufex Microsurgical, Inc. · General & Plastic Surgery device
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Feb 1989
Decision
118d
Days
Class 1
Risk

K884565 is an FDA 510(k) clearance for the ACUFEX FIXATION BUTTON. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Norwood, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 118 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4930 - 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 K884565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1988
Decision Date February 27, 1989
Days to Decision 118 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
4d slower than avg
Panel avg: 114d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGS Retention Device, Suture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4930
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.