Cleared Traditional

K132423 - THE GYNOCULAR

K132423 is an FDA 510(k) clearance for THE GYNOCULAR, manufactured by Gynius AB. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K132423 · Gynius AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
246d
Days
Class 2
Risk

K132423 is an FDA 510(k) clearance for the THE GYNOCULAR. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Gynius AB (Stockholm, SE). The FDA issued a Cleared decision on April 8, 2014 after a review of 246 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.

FDA 510(k) Submission Details - K132423

510(k) Number K132423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2013
Decision Date April 08, 2014
Days to Decision 246 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
85d slower than avg
Panel avg: 161d · This submission: 246d
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 49
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K132423.
Video Colposcope
K151878 · Edan Instruments, Inc. · Dec 2015
LT-300 Video Colposcope
K143119 · Lutech Industries, Inc. · Dec 2014
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K140754 · CooperSurgical, Inc. · Oct 2014
GC-3000E DIGITAL COLPOSCOPE
K122311 · Shenzhen Goldcare Meditech Co., Ltd. · Sep 2013
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
K122973 · Medgyn Products, Inc. · Jun 2013
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
K110147 · Sti Medical Systems, LLC · Apr 2011
K132423 · THE GYNOCULAR
Download PDF FDA Summary Gynius AB