Cleared Traditional

K915051 - MODIFICATION MODEL 7201 INSUFFLATOR

K915051 is an FDA 510(k) clearance for MODIFICATION MODEL 7201 INSUFFLATOR, manufactured by Northgate Technologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K915051 · Northgate Technologies, Inc. · Obstetrics & Gynecology device
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Jun 1992
Decision
251d
Days
Class 2
Risk

K915051 is an FDA 510(k) clearance for the MODIFICATION MODEL 7201 INSUFFLATOR. 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 June 4, 1992 after a review of 251 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.

FDA 510(k) Submission Details - K915051

510(k) Number K915051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1991
Decision Date June 04, 1992
Days to Decision 251 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
90d slower than avg
Panel avg: 161d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

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 178
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K915051.
DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900
K921963 · Sun Medical, Inc. · Sep 1992
INSUFFLATOR, LAPAROSCOPIC
K920959 · Mectra Labs, Inc. · Jul 1992
MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR
K915694 · Medical Devices, Inc. · Jun 1992
SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700
K920986 · Snowden-Pencer · Jun 1992
CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR
K920114 · Spiess Design, Inc. · Apr 1992
OTT INSUFFLATOR FILTER PLUS/TUBING SET
K914153 · Marlo Surgical Technology · Apr 1992
K915051 · MODIFICATION MODEL 7201 INSUFFLATOR
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