# K071754: Neo-Vagina Surgery Set and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jan 7, 2009 after 559 days
- Product code: HDX (Dilator, Vaginal)
- Device class: 2
- Regulation: 21 CFR 884.3900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003380 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003380: Bioteque Vaginal Dilator, Bioteque America, Inc. (2001) Summary page 1.
- K033310: Remeex System for Urinary Incontinence, Specialities Remeex International, S.L. (2004) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K071754
Methodology: https://510kreport.com/methodology