Cleared Traditional

K960144 - G.E. STERILE CT BIOPSY TRAY
(FDA 510(k) Clearance)

K960144 · GE Medical Systems · Cardiovascular

Apr 1996

Decision

90d

Days

Class 1

Risk

K960144 is an FDA 510(k) clearance for the G.E. STERILE CT BIOPSY TRAY, a Instruments, Surgical, Cardiovascular (Class I — General Controls, product code DWS), submitted by GE Medical Systems (Palm Harbor, US). The FDA issued a Cleared decision on April 15, 1996, 90 days after receiving the submission on January 16, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4500.

Submission Details

510(k) Number	K960144 FDA.gov
FDA Decision	Cleared SESK
Date Received	January 16, 1996
Decision Date	April 15, 1996
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement