Cleared Traditional

K915694 - MEDITRON ELECTRONIC LAPAROSCOPIC INSUFF...

K915694 is an FDA 510(k) clearance for MEDITRON ELECTRONIC LAPAROSCOPIC INSUFF..., manufactured by Medical Devices, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K915694 · Medical Devices, Inc. · Obstetrics & Gynecology device
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Jun 1992
Decision
178d
Days
Class 2
Risk

K915694 is an FDA 510(k) clearance for the MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Medical Devices, Inc. (Hackensack, US). The FDA issued a Cleared decision on June 18, 1992 after a review of 178 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.

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FDA 510(k) Submission Details - K915694

510(k) Number K915694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1991
Decision Date June 18, 1992
Days to Decision 178 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
18d slower than avg
Panel avg: 160d · This submission: 178d
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 82
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K915694.
INFILTUBE
K925558 · Medsurg Industries, Inc. · Mar 1994
INSUFFLATOR TUBING/FILTER KIT
K922244 · O.R. Concepts, Inc. · Sep 1993
MEDICAM 900 INSUFFLATOR WITH ACCESSORIES
K921837 · Kirschner Medical Corp. · Feb 1993
MODIFICATION MODEL 7201 INSUFFLATOR
K915051 · Northgate Technologies, Inc. · Jun 1992
OTT INSUFFLATOR FILTER PLUS/TUBING SET
K914153 · Marlo Surgical Technology · Apr 1992
SYSTEM 3000 ELECTRONIC INSUFFLATOR
K913873 · Cabot Medical Corp. · Mar 1992