510(k) · Cleared
ClearedNeo-Vagina Surgery Set and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · HDX Dilator, Vaginal
Cleared on Jan 7, 2009 as substantially equivalent to K003380 (Bioteque America, Inc., 2001) and 1 other predicate after a 559-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jan 7, 2009
- Review
- 559 days
- Class
- Class II
- Product code
- HDX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003380 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK003380 Bioteque Vaginal DilatorBioteque America, Inc. · 2001
- This deviceK071754 Neo-Vagina Surgery Set and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003380 | Bioteque Vaginal Dilator | Bioteque America, Inc. | 2001 | — |
| 0 (this device) | K071754 | Neo-Vagina Surgery Set and Accessories | KARL STORZ Endoscopy-America, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 HDX? 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 HDX device
- #1 K241748 Intimate Rose Vaginal Dilatorsscore 8.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K003380 | Bioteque Vaginal DilatorSummary page 1…Vaginal Dilator Classification Name: Vaginal Stent Regulation Number: 21 CFR 84.3900 Product Code: HDX Predicate Device(s): Bioteque America, Inc. (K003380) Specialities REMEEX International, S.L. (K033310) Device Description: The KSEA Neo-vagina Surgery Set… | 2001 |
| * | K033310 | Remeex System for Urinary IncontinenceSummary page 1…: 21 CFR 84.3900 Product Code: HDX Predicate Device(s): Bioteque America, Inc. (K003380) Specialities REMEEX International, S.L. (K033310) Device Description: The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified… | 2004 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All HDX devicesHDX Dilator, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HDX
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HDX
314in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HDX
No recall names HDX since 2007.
Adverse event reports per year · HDX
1in 2025
MAUDE reports naming product code HDX, 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 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 3 | 314 | 0 | 1 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons in women with congenital absence of the vagina who have failed first-line non-surgical treatment with conventional vaginal dilators. The set is used in conjunction with a laparoscopic surgical procedure to create and enlarge the vaginal cavity via continuous traction between the abdomen and vulva, and to maintain the vaginal canal after surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071754: Neo-Vagina Surgery Set and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071754
Report an extraction error
Are you the manufacturer?
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