Goldway Digital Video Colposcope Imaging System, Model #SLC-2000

FDA 510(k) K021153 · Goldway Us, Inc.

Substantially Equivalent

510(k) numberK021153

Submission

Device name
Goldway Digital Video Colposcope Imaging System, Model #SLC-2000
Applicant
Goldway Us, Inc.
San Jose, CA, US
Received
April 10, 2002
Decision date
February 10, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HEX – Colposcope (And Colpomicroscope)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1630
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HEX

510(k)DeviceApplicantDecision
K233043Smart Scope® CXHEX · Traditional Periwinkle Technologies Pvt., Ltd.06/14/2024SE
K190187Gynescope SystemHEX · Traditional Illumigyn , Ltd.05/08/2019SE
K182764Biop Digital ColposcopeHEX · Traditional Biop Medical , Ltd.11/27/2018SE
K181034Pocket Colposcope SystemHEX · Traditional Hadleigh Health Technologies, LLC09/21/2018SE
K170446LT-300 SD Digital Video ColposcopeHEX · Traditional Lutech Industries, Inc.05/21/2017SE
K161871EVA (Enhanced Visual Assessment) SystemHEX · Traditional Mobileodt , Ltd.12/19/2016SE
K160341Colposcope SystemHEX · Traditional Xuzhou Kernel Medical Equipment Co., Ltd.09/14/2016SE
K160380LT-300 HDHEX · Traditional Lutech Industries, Inc.05/13/2016SE
K151878Video ColposcopeHEX · Traditional Edan Instruments, Inc.12/01/2015SE
K143119LT-300 Video ColposcopeHEX · Traditional Lutech Industries, Inc.12/18/2014SE

More from Lutech Industries, Inc.

510(k)DeviceDecision
K112877Comen Multi-Parameter Patient MonitorMWI · Traditional 11/07/2012SE
K033988Goldway UT4000A Vital Signs MonitorMWI · Traditional 02/25/2004SE
K021154Goldway Patient Monitor, Model # UT4000FMWI · Traditional 04/11/2003SE

Questions and answers

When was Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 cleared by the FDA?

Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 (K021153) received a 510(k) decision of Substantially Equivalent on February 10, 2003, 306 days after the submission was received.

What is the product code of K021153?

The FDA product code is HEX – Colposcope (And Colpomicroscope), a Class II (moderate risk) device regulated under 21 CFR 884.1630.