Cleared Traditional

K941740 - ACUFEX ROTATOR CUFF FIXATION BUTTON

K941740 is the FDA 510(k) clearance for ACUFEX ROTATOR CUFF FIXATION BUTTON by Acufex Microsurgical, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGS) cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K941740 · Acufex Microsurgical, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
334d slower than avg
Panel avg: 115d · 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.

Regulatory Peers - KGS Retention Device, Suture

All 11
Devices cleared under the same product code (KGS) and FDA review panel - the closest regulatory comparables to K941740.
RBM
K020480 · Smith & Nephew, Inc. · Mar 2002
VENTROFIL TENSION RELIEF SUTURE SET
K904435 · Aesculap, Inc. · Aug 1991
SURGICAL RETENTION BAR
K902001 · Acufex Microsurgical, Inc. · May 1990
ACUFEX FIXATION BUTTON
K896310 · Acufex Microsurgical, Inc. · Nov 1989
ACUFEX FIXATION BUTTON
K884565 · Acufex Microsurgical, Inc. · Feb 1989
HEWSON A.C.L. GUIDE SET
K872608 · Concept, Inc. · Sep 1987