Cleared Traditional

K122311 - GC-3000E DIGITAL COLPOSCOPE

K122311 is an FDA 510(k) clearance for GC-3000E DIGITAL COLPOSCOPE, manufactured by Shenzhen Goldcare Meditech Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 413-day FDA review.

K122311 · Shenzhen Goldcare Meditech Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
413d
Days
Class 2
Risk

K122311 is an FDA 510(k) clearance for the GC-3000E DIGITAL COLPOSCOPE. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Shenzhen Goldcare Meditech Co., Ltd. (San Marino, US). The FDA issued a Cleared decision on September 18, 2013 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Shenzhen Goldcare Meditech Co., Ltd. devices

FDA 510(k) Submission Details - K122311

510(k) Number K122311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2012
Decision Date September 18, 2013
Days to Decision 413 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
252d slower than avg
Panel avg: 161d · This submission: 413d
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 45
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K122311.
LT-300 Video Colposcope
K143119 · Lutech Industries, Inc. · Dec 2014
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K140754 · CooperSurgical, Inc. · Oct 2014
THE GYNOCULAR
K132423 · Gynius AB · Apr 2014
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
DYSIS
K092433 · Forth Photonics Hellas SA · Mar 2011