Cleared Traditional

K160341 - Colposcope System

K160341 is an FDA 510(k) clearance for Colposcope System, manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K160341 · Xuzhou Kernel Medical Equipment Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
219d
Days
Class 2
Risk

K160341 is an FDA 510(k) clearance for the Colposcope System. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Xuzhou Kernel Medical Equipment Co., Ltd. (Xuzhou, CN). The FDA issued a Cleared decision on September 14, 2016 after a review of 219 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 Xuzhou Kernel Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K160341

510(k) Number K160341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2016
Decision Date September 14, 2016
Days to Decision 219 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
59d slower than avg
Panel avg: 160d · This submission: 219d
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 18
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K160341.
Gynescope System
K190187 · Illumigyn , Ltd. · May 2019
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
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K140754 · CooperSurgical, Inc. · Oct 2014
IMAGE MANAGEMENT SYSTEM
K033870 · Welch Allyn, Inc. · Mar 2004