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510(k) K233043

Device
Smart Scope® CX
Applicant
Periwinkle Technologies Pvt., Ltd.
510(k) number
K233043
Product code
HEX
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-14
Date received
2023-09-25
Regulation
884.1630
Classification name
Colposcope (And Colpomicroscope)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Veena Moktali
Address
B1, Samrat Ashok Chs, S. # 88/2, Veerbhadra Nagar, Baner, Pune IN 411045 411045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HEX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K190187Gynescope SystemIllumigyn , Ltd.2019-05-08
K182764Biop Digital ColposcopeBiop Medical , Ltd.2018-11-27
K181034Pocket Colposcope SystemHadleigh Health Technologies, LLC2018-09-21
K170446LT-300 SD Digital Video ColposcopeLutech Industries, Inc.2017-05-21
K161871EVA (Enhanced Visual Assessment) SystemMobileodt , Ltd.2016-12-19
K160341Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd.2016-09-14
K160380LT-300 HDLutech Industries, Inc.2016-05-13
K151878Video ColposcopeEdan Instruments, Inc.2015-12-01
K143119LT-300 Video ColposcopeLutech Industries, Inc.2014-12-18
K140754COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEMCooperSurgical, Inc.2014-10-23
K132423THE GYNOCULARGynius AB2014-04-08
K122311GC-3000E DIGITAL COLPOSCOPEShenzhen Goldcare Meditech Co., Ltd.2013-09-18
K122973AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPEMedgyn Products, Inc.2013-06-12
K110147ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINESti Medical Systems, LLC2011-04-08
K092433DYSISForth Photonics Hellas SA2011-03-10