510(k) · Cleared
ClearedGelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · HEW Culdoscope (And Accessories)
Cleared on Oct 2, 2025 as substantially equivalent to K191294 (Applied Medical Resources Corp., 2019) after a 367-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Oct 2, 2025
- Review
- 367 days
- Class
- Class II
- Product code
- HEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954311 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK954311 Koh Colpotomizer SystemCooperSurgical, Inc. · 1996 · Recalled
- 3 generations backK051594 Mccartney Access TubeGynetech Pty., Ltd. · 2005
- 2 generations backK143308 GelPOINT Transvaginal Access PlatformApplied Medical Resources · 2015
- 1 generation backK191294 Transvaginal Access PlatformApplied Medical Resources Corp. · 2019
- This deviceK243152 GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal…Applied Medical Resources Corp. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954311 | Koh Colpotomizer System | CooperSurgical, Inc. | 1996 | 2 |
| −3 | K051594 | Mccartney Access Tube | Gynetech Pty., Ltd. | 2005 | — |
| −2 | K143308 | GelPOINT Transvaginal Access Platform | Applied Medical Resources | 2015 | — |
| −1 | K191294 | Transvaginal Access Platform | Applied Medical Resources Corp. | 2019 | — |
| 0 (this device) | K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Applied Medical Resources Corp. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HEW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HEW device
- #1 K201086 Advincula Delineator Uterine Manipulatorscore -0.0 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191294 | Transvaginal Access PlatformSummary page 6…Device Class: Class II Product Code: HEW Predicate Device: Trade Name: Transvaginal Access Platform 510(k) #: K191294 Product Code: HEW No design-related recalls for the predicate device have been… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All HEW devicesHEW Culdoscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HEW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HEW
Too few HEW 510(k)s in any year since 2007 to give a median.
Recalls per year · HEW
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HEW
20in 2025
MAUDE reports naming product code HEW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 1 | — | 1 | 14 |
| 2019 | 1 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 35 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 20 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and maintain insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device may be used for sentinel pelvic lymph node dissection occurring in the retroperitoneal space. The device is also a conduit for the extraction of specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243152: GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243152
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026