Cleared Traditional

K935862 - NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL...

K935862 is the FDA 510(k) clearance for NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL... by Northgate Technologies, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K935862 · Northgate Technologies, Inc. · Obstetrics & Gynecology device
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Aug 1994
Decision
259d
Days
Class 2
Risk

K935862 is an FDA 510(k) clearance for the NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600. 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 August 19, 1994 after a review of 259 days - an extended review 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: 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 K935862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1993
Decision Date August 19, 1994
Days to Decision 259 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
99d slower than avg
Panel avg: 160d · This submission: 259d
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 K935862.
DEXIDE INSUFFLATION TUBING WITH FILTER
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DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER
K945789 · Deroyal Industries, Inc. · Feb 1995
ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER
K943954 · Conmedcorp · Nov 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
K934043 · KARL STORZ Endoscopy-America, Inc. · May 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
K934114 · KARL STORZ Endoscopy-America, Inc. · May 1994
ELECTRONIC INSUFFLATOR MODEL 2054.61
K921756 · Richard Wolf Medical Instruments Corp. · Mar 1994