510(k) · Cleared
ClearedTransvaginal Access Platform
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 Sep 6, 2019 as substantially equivalent to K143308 (Applied Medical Resources, 2015) after a 115-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Sep 6, 2019
- Review
- 115 days
- Class
- Class II
- Product code
- HEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954311 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK954311 Koh Colpotomizer SystemCooperSurgical, Inc. · 1996 · Recalled
- 2 generations backK051594 Mccartney Access TubeGynetech Pty., Ltd. · 2005
- 1 generation backK143308 GelPOINT Transvaginal Access PlatformApplied Medical Resources · 2015
- This deviceK191294 Transvaginal Access PlatformApplied Medical Resources Corp. · 2019
- Descendant · cites it directly · 0 of its ownK243152 GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal…Applied Medical Resources Corp. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceApplied Medical Resources Corp. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954311 | Koh Colpotomizer System | CooperSurgical, Inc. | 1996 | 2 |
| −2 | K051594 | Mccartney Access Tube | Gynetech Pty., Ltd. | 2005 | — |
| −1 | K143308 | GelPOINT Transvaginal Access Platform | Applied Medical Resources | 2015 | — |
| 0 (this device) | K191294 | Transvaginal Access Platform | Applied Medical Resources Corp. | 2019 | — |
| +1 | K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Applied Medical Resources Corp. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 K243152 GelPOINT V-Path Transvaginal Access Platform…score 11.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K143308 | GelPOINT Transvaginal Access PlatformSummary page 4…Product Code: HEW (culdoscope and accessories) Predicate Device: Trade Name: GelPOINT Transvaginal Access Platform 510(k) #: K143308 Product Code: HEW The predicate device has not been subject to a design related rec… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | 2025 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K243152 (Applied Medical Resources Corp., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HEW devicesHEW Culdoscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device is also a conduit for the extraction of specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191294: Transvaginal Access Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191294
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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