Cleared Traditional

K931065 - LAPAROVIEW
(FDA 510(k) Clearance)

K931065 · Northgate Technologies, Inc. · Obstetrics & Gynecology

Nov 1994

Decision

639d

Days

Class 2

Risk

K931065 is an FDA 510(k) clearance for the LAPAROVIEW, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on November 30, 1994, 639 days after receiving the submission on March 1, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number	K931065 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 1993
Decision Date	November 30, 1994
Days to Decision	639 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement