Cleared Traditional

K880195 - GYNESCOPE

K880195 is an FDA 510(k) clearance for GYNESCOPE, manufactured by Medgyn Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K880195 · Medgyn Products, Inc. · Obstetrics & Gynecology device
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Mar 1988
Decision
48d
Days
Class 2
Risk

K880195 is an FDA 510(k) clearance for the GYNESCOPE. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Medgyn Products, Inc. (Downers Grove, US). The FDA issued a Cleared decision on March 14, 1988 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1630 - 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 Medgyn Products, Inc. devices

FDA 510(k) Submission Details - K880195

510(k) Number K880195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date March 14, 1988
Days to Decision 48 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 160d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEX Device Classification - Class 2, Special Controls

Product Code HEX Colposcope (and Colpomicroscope)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1630
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 - HEX Colposcope (and Colpomicroscope)

All 27
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K880195.
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
K955635 · Welch Allyn, Inc. · May 1996
MALLEABLE PLACENTA CURETTE
K890387 · Kinetic Medical Products · Feb 1989
JEDMED KP6 COLPOSCOPE
K884934 · Jedmed Instrument Co. · Feb 1989
PHOTOSTAR V-8
K871681 · Wallach Surgical Devices, Inc. · Aug 1987
COLPOSTAR V-6
K871683 · Wallach Surgical Devices, Inc. · Aug 1987
WALLACH CONVERTIBLE COLPOSCOPE
K871682 · Wallach Surgical Devices, Inc. · Jun 1987