Cleared Traditional

BIOACCESS MARROW HARVEST SYSTEM

K971114 · Bioaccess, Inc. · General & Plastic Surgery

Jun 1997

Decision

69d

Days

Class 1

Risk

About This 510(k) Submission

K971114 is an FDA 510(k) clearance for the BIOACCESS MARROW HARVEST SYSTEM, a Needle, Aspiration And Injection, Reusable (Class I — General Controls, product code GDM), submitted by Bioaccess, Inc. (Silver Spring, US). The FDA issued a Cleared decision on June 3, 1997, 69 days after receiving the submission on March 26, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K971114 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 1997
Decision Date	June 03, 1997
Days to Decision	69 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF