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510(k) K243152

Device
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
Applicant
Applied Medical Resources Corp.
510(k) number
K243152
Product code
HEW
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-02
Date received
2024-09-30
Regulation
884.1640
Classification name
Culdoscope (And Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Apeksha Shanbhag
Address
22872 Avenida Empresa Rancho Santa CA US 92688 92688

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HEW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201086Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.2020-05-21
K191294Transvaginal Access PlatformApplied Medical Resources Corp.2019-09-06
K180429Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.2018-03-14
K161065ColpoWave™ Colpotomizer and CerviGrip™ Uterine ManipulatorSurgitools Pty , Ltd.2016-10-27
K143308GelPOINT Transvaginal Access PlatformApplied Medical Resources2015-10-13
K143650CooperSurgical Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.2015-07-21
K111014LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIESLsi Solutions, Inc.2012-07-13
K110819SINGHMED ROOLIP MANIPULATORJ.Singh Instruments2011-10-05
K051160MANIPUSEALInsitu Systems2005-09-02
K051594MCCARTNEY ACCESS TUBEGynetech Pty. , Ltd.2005-09-02
K033728TRANSVAGINAL ENDOSCOPY SETKARL STORZ Endoscopy-America, Inc.2004-02-27
K992655FERTILOSCOPY KIT FH 1.29/FTO 1.40Soprane S.A.2000-03-13
K993804KSEA RIGID CULDOSCOPE AND ACCESSORIESKARL STORZ Endoscopy-America, Inc.2000-02-07
K980972RIGID CULDOSCOPE AND ACCESSORIESCircon Corp.1998-06-12
K964276ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATORRichard Wolf Medical Instruments Corp.1997-11-25