Cleared Traditional

K941740 - ACUFEX ROTATOR CUFF FIXATION BUTTON (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K941740 · Acufex Microsurgical, Inc. · General & Plastic Surgery device
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Jun 1995
Decision
449d
Days
Class 1
Risk

K941740 is an FDA 510(k) clearance for the ACUFEX ROTATOR CUFF FIXATION BUTTON. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on June 30, 1995 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K941740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1994
Decision Date June 30, 1995
Days to Decision 449 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
335d slower than avg
Panel avg: 114d · This submission: 449d
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.