Cleared Traditional

K896310 - ACUFEX FIXATION BUTTON

Also marketed or referenced as:
RETENTION BAR, WEDGE

K896310 is an FDA 510(k) clearance for ACUFEX FIXATION BUTTON, manufactured by Acufex Microsurgical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGS cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K896310 · Acufex Microsurgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Nov 1989
Decision
19d
Days
Class 1
Risk

K896310 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 November 20, 1989 after a review of 19 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K896310

510(k) Number K896310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1989
Decision Date November 20, 1989
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

KGS Device Classification - Class 1, General Controls

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 19
Devices cleared under the same product code (KGS) and FDA review panel - the closest regulatory comparables to K896310.
TRAY DOUGH
K911225 · The Hygenic Corp. · Apr 1991
SUTURE TENSION ADJUSTMENT REEL
K904136 · Surgical Systems, Inc. · Oct 1990
SURGICAL RETENTION BAR
K902001 · Acufex Microsurgical, Inc. · May 1990
DERMACARE TIE HOLDER
K893995 · Dermacare · Aug 1989
ACUFEX FIXATION BUTTON
K884565 · Acufex Microsurgical, Inc. · Feb 1989
SUTURE RETENTION DEVICE
K883299 · Edwards Orthopaedics Div., Baxter Healthcare Corp. · Aug 1988
K896310 · ACUFEX FIXATION BUTTON
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