Cleared Special

CO2 GAS WARMER II, MODEL 6-800-00

K992381 · Northgate Technologies, Inc. · Obstetrics & Gynecology
Sep 1999
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K992381 is an FDA 510(k) clearance for the CO2 GAS WARMER II, MODEL 6-800-00, a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on September 17, 1999, 63 days after receiving the submission on July 16, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.

Submission Details

510(k) Number K992381 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1999
Decision Date September 17, 1999
Days to Decision 63 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIF — Insufflator, Laparoscopic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1730

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