Transvaginal Access Platform
FDA 510(k) K191294 · Applied Medical Resources Corp.
510(k) numberK191294
Submission
- Device name
- Transvaginal Access Platform
- Applicant
- Applied Medical Resources Corp.
Rancho Santa, CA, US - Received
- May 14, 2019
- Decision date
- September 6, 2019
- 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
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW · Traditional | Applied Medical Resources Corp. | 10/02/2025SE |
| K201086 | Advincula Delineator Uterine ManipulatorHEW · Special | CooperSurgical, Inc. | 05/21/2020SE |
| 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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| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)GEI · Traditional | 10/31/2025SE |
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW · Traditional | 10/02/2025SE |
| K232880 | Inzii Ripstop Redeployable Retrieval SystemGCJ · Special | 11/01/2023SE |
| K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)GEI · Special | 10/14/2022SE |
| K220969 | GelPOINT V-Path Vaginal Access SystemMOK · Traditional | 09/16/2022SE |
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Questions and answers
When was Transvaginal Access Platform cleared by the FDA?
Transvaginal Access Platform (K191294) received a 510(k) decision of Substantially Equivalent on September 6, 2019, 115 days after the submission was received.
What is the product code of K191294?
The FDA product code is HEW – Culdoscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1640.