Cleared Traditional

K965028 - ACUMED SUTURE WASHER
(FDA 510(k) Clearance)

K965028 · Acu Med, Inc. · Orthopedic device

Mar 1997

Decision

90d

Days

Class 2

Risk

K965028 is an FDA 510(k) clearance for the ACUMED SUTURE WASHER. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on March 17, 1997, 90 days after receiving the submission on December 17, 1996.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K965028 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 17, 1996
Decision Date	March 17, 1997
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF