Cleared Traditional

K151878 - Video Colposcope

K151878 is an FDA 510(k) clearance for Video Colposcope, manufactured by Edan Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K151878 · Edan Instruments, Inc. · Obstetrics & Gynecology device
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Dec 2015
Decision
145d
Days
Class 2
Risk

K151878 is an FDA 510(k) clearance for the Video Colposcope. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 1, 2015 after a review of 145 days - within the typical 510(k) review window.

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 Edan Instruments, Inc. devices

FDA 510(k) Submission Details - K151878

510(k) Number K151878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2015
Decision Date December 01, 2015
Days to Decision 145 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
15d faster than avg
Panel avg: 160d · This submission: 145d
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 Consultant

Edan Medical
Doug Worth

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HEX Colposcope (and Colpomicroscope)

All 17
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K151878.
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
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K140754 · CooperSurgical, Inc. · Oct 2014
IMAGE MANAGEMENT SYSTEM
K033870 · Welch Allyn, Inc. · Mar 2004
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
K972630 · CooperSurgical, Inc. · Feb 1998