Cleared Traditional

K880376 - NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP
(FDA 510(k) Clearance)

K880376 · Genesis Industries, Inc. · General & Plastic Surgery

Feb 1988

Decision

20d

Days

Class 1

Risk

K880376 is an FDA 510(k) clearance for the NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP, a Catheter, Ventricular, General & Plastic Surgery (Class I — General Controls, product code GBS), submitted by Genesis Industries, Inc. (Spring Valley, US). The FDA issued a Cleared decision on February 16, 1988, 20 days after receiving the submission on January 27, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number	K880376 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 1988
Decision Date	February 16, 1988
Days to Decision	20 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—