GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
FDA 510(k) K243152 · Applied Medical Resources Corp.
510(k) numberK243152
Submission
- Device name
- GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
- Applicant
- Applied Medical Resources Corp.
Rancho Santa, CA, US - Received
- September 30, 2024
- Decision date
- October 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HEW – Culdoscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1640
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201086 | Advincula Delineator Uterine ManipulatorHEW · Special | CooperSurgical, Inc. | 05/21/2020SE |
| K191294 | Transvaginal Access PlatformHEW · Traditional | Applied Medical Resources Corp. | 09/06/2019SE |
| K180429 | Advincula Delineator Uterine ManipulatorHEW · Special | CooperSurgical, Inc. | 03/14/2018SE |
| K161065 | ColpoWave Colpotomizer and CerviGrip Uterine ManipulatorHEW · Traditional | Surgitools Pty , Ltd. | 10/27/2016SE |
| K143308 | GelPOINT Transvaginal Access PlatformHEW · Traditional | Applied Medical Resources | 10/13/2015SE |
| K143650 | CooperSurgical Advincula Delineator Uterine ManipulatorHEW · Traditional | CooperSurgical, Inc. | 07/21/2015SE |
| K111014 | Lsi Solutions Fornisee System Uterine Manipulator and AccessoriesHEW · Traditional | Lsi Solutions, Inc. | 07/13/2012SE |
| K110819 | Singhmed Roolip ManipulatorHEW · Traditional | J.Singh Instruments | 10/05/2011SE |
| K051594 | Mccartney Access TubeHEW · Traditional | Gynetech Pty. , Ltd. | 09/02/2005SE |
| K051160 | ManipusealHEW · Traditional | Insitu Systems | 09/02/2005SE |
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Questions and answers
When was GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device cleared by the FDA?
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (K243152) received a 510(k) decision of Substantially Equivalent on October 2, 2025, 367 days after the submission was received.
What is the product code of K243152?
The FDA product code is HEW – Culdoscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1640.