Cleared Traditional

K914401 - UNIVERSAL GENERAL USE KIT #7-510-16

K914401 is the FDA 510(k) clearance for UNIVERSAL GENERAL USE KIT #7-510-16 by Northgate Technologies, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K914401 · Northgate Technologies, Inc. · Obstetrics & Gynecology device
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Nov 1991
Decision
56d
Days
Class 2
Risk

K914401 is an FDA 510(k) clearance for the UNIVERSAL GENERAL USE KIT #7-510-16. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Northgate Technologies, Inc. devices

Submission Details

510(k) Number K914401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1991
Decision Date November 27, 1991
Days to Decision 56 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 160d · This submission: 56d
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 K914401.
MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR
K915694 · Medical Devices, Inc. · Jun 1992
MODIFICATION MODEL 7201 INSUFFLATOR
K915051 · Northgate Technologies, Inc. · Jun 1992
SYSTEM 3000 ELECTRONIC INSUFFLATOR
K913873 · Cabot Medical Corp. · Mar 1992
RECIRCULATION KIT #7-510-18
K914402 · Northgate Technologies, Inc. · Nov 1991
GENERAL USE KIT #7-510-20
K914403 · Northgate Technologies, Inc. · Nov 1991
VERRES NEEDLES 5 & 6 INCHES
K911179 · Northgate Technologies, Inc. · Nov 1991