Cleared Traditional

K022052 - 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
(FDA 510(k) Clearance)

K022052 · Northgate Technologies, Inc. · Obstetrics & Gynecology

Jan 2003

Decision

214d

Days

Class 2

Risk

K022052 is an FDA 510(k) clearance for the 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0, a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on January 24, 2003, 214 days after receiving the submission on June 24, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.

Submission Details

510(k) Number	K022052 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 2002
Decision Date	January 24, 2003
Days to Decision	214 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF