Cleared Traditional

K944079 - IMAGYN MICROLAP(TM) LAPAROSCOPE

K944079 is an FDA 510(k) clearance for IMAGYN MICROLAP(TM) LAPAROSCOPE, manufactured by Imagyn Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K944079 · Imagyn Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
151d
Days
Class 2
Risk

K944079 is an FDA 510(k) clearance for the IMAGYN MICROLAP(TM) LAPAROSCOPE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Imagyn Medical, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on January 20, 1995 after a review of 151 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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 Imagyn Medical, Inc. devices

FDA 510(k) Submission Details - K944079

510(k) Number K944079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1994
Decision Date January 20, 1995
Days to Decision 151 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 160d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 166
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K944079.
TROCAR AND CANNULA ACCESSORY
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KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE
K945100 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360
K936273 · Baxter Healthcare Corp · Jan 1995
ENDOSCOPE
K944555 · United States Surgical, A Division of Tyco Healthc · Dec 1994
CONMED TROGARD
K934799 · Conmedcorp · Dec 1994