Cleared Special

K992381 - CO2 GAS WARMER II

K992381 is the FDA 510(k) clearance for CO2 GAS WARMER II by Northgate Technologies, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Special 510(k) pathway after a 63-day FDA review.

K992381 · Northgate Technologies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
63d
Days
Class 2
Risk

K992381 is an FDA 510(k) clearance for the CO2 GAS WARMER II, MODEL 6-800-00. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on September 17, 1999 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Northgate Technologies, Inc. devices

Submission Details

510(k) Number K992381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 160d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 81
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K992381.
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
K000180 · Richard Wolf Medical Instruments Corp. · Mar 2001
STRYKER HEATED INSUFFLATOR TUBE SET
K003792 · Stryker Corp. · Feb 2001
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
K991906 · Richard Wolf Medical Instruments Corp. · Nov 1999
OMNIFLATOR 7640 MODEL 7-640-00
K983326 · Northgate Technologies, Inc. · Feb 1999
ENDOPATH ULTRA VERESS NEEDLE
K983925 · Ethicon Endo-Surgery, Inc. · Feb 1999
CO2 GAS WARMING UNIT (6-800-00)
K972675 · Northgate Technologies, Inc. · Sep 1998