Cleared Traditional

K965055 - IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES

K965055 is an FDA 510(k) clearance for IMAGYN MICROLAP AND MICRO LAP-GOLD LAPA..., 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 78-day FDA review.

K965055 · Imagyn Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
78d
Days
Class 2
Risk

K965055 is an FDA 510(k) clearance for the IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES. 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 March 6, 1997 after a review of 78 days - a notably fast clearance 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: 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 Imagyn Medical, Inc. devices

FDA 510(k) Submission Details - K965055

510(k) Number K965055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1996
Decision Date March 06, 1997
Days to Decision 78 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 160d · This submission: 78d
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 228
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K965055.
LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
K963076 · Louisville Laboratories, Inc. · Apr 1997
CANNULA
K965121 · Origin Medsystems, Inc. · Mar 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K970151 · Smith & Nephew, Inc. · Mar 1997
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS
K970105 · Richard Wolf Medical Instruments Corp. · Mar 1997
S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
K960640 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Feb 1997
RIGID FIBER OPTIC LAPAROSCOPE
K962246 · Health Care International Assoc. · Feb 1997