Cleared Traditional

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

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

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

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on June 30, 1995, 449 days after receiving the submission on April 7, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4930.

Submission Details

510(k) Number K941740 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KGS — Retention Device, Suture
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4930