Cleared Traditional

K122973 - AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE

K122973 is an FDA 510(k) clearance for AL-106, 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 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

FDA 510(k) Submission Details - K122973

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
Combination Product No
PCCP Authorized No
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.

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 25
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K122973.
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K140754 · CooperSurgical, Inc. · Oct 2014
THE GYNOCULAR
K132423 · Gynius AB · Apr 2014
GC-3000E DIGITAL COLPOSCOPE
K122311 · Shenzhen Goldcare Meditech Co., Ltd. · Sep 2013
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
K110147 · Sti Medical Systems, LLC · Apr 2011
IMAGE MANAGEMENT SYSTEM
K033870 · Welch Allyn, Inc. · Mar 2004
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
K992544 · Circon Corp. · Oct 1999