Cleared Traditional

K021153 - GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000

K021153 is an FDA 510(k) clearance for GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGIN..., manufactured by Goldway Us, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K021153 · Goldway Us, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
306d
Days
Class 2
Risk

K021153 is an FDA 510(k) clearance for the GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Goldway Us, Inc. (San Jose, US). The FDA issued a Cleared decision on February 10, 2003 after a review of 306 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K021153

510(k) Number K021153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2002
Decision Date February 10, 2003
Days to Decision 306 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
145d slower than avg
Panel avg: 161d · This submission: 306d
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 46
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K021153.
IMAGE MANAGEMENT SYSTEM
K033870 · Welch Allyn, Inc. · Mar 2004
MEDISCOPE
K031436 · Sometech Corporation · Dec 2003
INTERMED ZOOM COLPOSCOPE
K031639 · Intermed Group, Inc. · Aug 2003
DFV CPG COLPOSCOPE
K021854 · D.F. Vasconcellos S.A. · Oct 2002
MEDSCOPE
K001314 · All-Pro Imaging Corp. · Jul 2000
LEICA COLPOSCOPE
K000707 · Leica Microscopy Systems , Ltd. · Jun 2000
K021153 · GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
Download PDF FDA Summary Goldway Us, Inc.