Cleared Traditional

K122973 - AL-106

K122973 is the FDA 510(k) clearance for AL-106 by Medgyn Products, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HEX) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K122973 · Medgyn Products, Inc. · Obstetrics & Gynecology device
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Jun 2013
Decision
259d
Days
Class 2
Risk

K122973 is an FDA 510(k) clearance for the AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Medgyn Products, Inc. (San Jose, US). The FDA issued a Cleared decision on June 12, 2013 after a review of 259 days - an extended review 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: 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 Medgyn Products, Inc. devices

Submission Details

510(k) Number K122973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2012
Decision Date June 12, 2013
Days to Decision 259 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
99d slower than avg
Panel avg: 160d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K122973.
Biop Digital Colposcope
K182764 · Biop Medical , Ltd. · Nov 2018
Pocket Colposcope System
K181034 · Hadleigh Health Technologies, LLC · Sep 2018
Video Colposcope
K151878 · Edan Instruments, Inc. · Dec 2015
IMAGE MANAGEMENT SYSTEM
K033870 · Welch Allyn, Inc. · Mar 2004
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
K955635 · Welch Allyn, Inc. · May 1996
MALLEABLE PLACENTA CURETTE
K890387 · Kinetic Medical Products · Feb 1989