Cleared Traditional

MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR (K912044) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912044 · Multigon Industries, Inc. · Obstetrics & Gynecology device
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Jun 1991
Decision
47d
Days
Class 2
Risk

K912044 is an FDA 510(k) clearance for the MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Multigon Industries, Inc. (Mt. Vernon, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 47 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 Multigon Industries, Inc. devices

Submission Details

510(k) Number K912044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1991
Decision Date June 24, 1991
Days to Decision 47 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 160d · This submission: 47d
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 38
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K912044.
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K951961 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
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K934043 · KARL STORZ Endoscopy-America, Inc. · May 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
K934114 · KARL STORZ Endoscopy-America, Inc. · May 1994
CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/
K871928 · Medline Industries, Inc. · Nov 1987
MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA
K845021 · Medline Industries, Inc. · May 1985