Cleared Traditional

K983326 - OMNIFLATOR 7640 MODEL 7-640-00

K983326 is the FDA 510(k) clearance for OMNIFLATOR 7640 MODEL 7-640-00 by Northgate Technologies, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K983326 · Northgate Technologies, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
136d
Days
Class 2
Risk

K983326 is an FDA 510(k) clearance for the OMNIFLATOR 7640 MODEL 7-640-00. 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 February 5, 1999 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Northgate Technologies, Inc. devices

Submission Details

510(k) Number K983326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1998
Decision Date February 05, 1999
Days to Decision 136 days
Submission Type Traditional
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
24d faster than avg
Panel avg: 160d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K983326.
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
CO2 GAS WARMER II, MODEL 6-800-00
K992381 · Northgate Technologies, Inc. · Sep 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
OMNIFLATOR 6630(6-630-00)
K973447 · Northgate Technologies, Inc. · Sep 1998