Cleared Traditional

AXIOM ATRAUM WOUND DRAINS

K883887 · Axiom, Inc. · General & Plastic Surgery

Feb 1989

Decision

157d

Days

Class 1

Risk

About This 510(k) Submission

K883887 is an FDA 510(k) clearance for the AXIOM ATRAUM WOUND DRAINS, a Catheter, Ventricular, General & Plastic Surgery (Class I — General Controls, product code GBS), submitted by Axiom, Inc. (Paramount, US). The FDA issued a Cleared decision on February 17, 1989, 157 days after receiving the submission on September 13, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number	K883887 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 1988
Decision Date	February 17, 1989
Days to Decision	157 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—