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FDA 510(k)

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device

K-Number: K243152 · 2025-10-02

ApplicantApplied Medical Resources Corp.
Decision Date2025-10-02
Product CodeHEW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is a medical device manufactured by Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2025-10-02 under approval number K243152. The device is classified under product code HEW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device?

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is a medical device that received FDA 510(k) clearance on 2025-10-02. It is manufactured by Applied Medical Resources Corp.. The 510(k) number is K243152.

When was GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device approved by the FDA?

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device received FDA 510(k) clearance on 2025-10-02, under approval number K243152.

What company makes GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device?

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is manufactured by Applied Medical Resources Corp..

What is the FDA product code for GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device?

The FDA product code for GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is HEW.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41790854 A Substance Use Disorder Virtual Treatment and Research Platform: A Proof of Concept. IEEE pulse (2025) PMID: 41672626 [Regulatory Requirements and Considerations of Aesthetic Injection Medical Devices in China, the USA and the European Union]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026)

Other Devices by Applied Medical Resources Corp.

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Related Devices (Code: HEW)

K161065ColpoWave™ Colpotomizer and CerviGrip™ Uterine ManipulatorSurgitools Pty , Ltd. K180429Advincula Delineator Uterine ManipulatorCooperSurgical, Inc. K191294Transvaginal Access PlatformApplied Medical Resources Corp. K201086Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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