# K983045: Amielle

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford USA, Inc.
- Decided: Nov 25, 1998 after 85 days
- Product code: KXP (Stent, 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Young's Vaginal Dilator: named in the summary without a submission number

## Most influential descendants
- K222492: Hope&Her Vaginal Dilators (2023), 0 descendants of its own

## Indications for use
The device is intended to trcat women suffering from vaginismus and dysparcunia. VAGINISMUS is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. DYSPAREUNIA is the pain experienced during sexual intercourse caused by physical and/oy emotional problems. The device comes in varying sizes, the most appropriate is then sclected by the physician for use by the paticnt and the patient’s partner as an assistant if appropriate. It is used as a tool to DILATE the vagina in controlled stages. The device can be autoclaved or sterilised by normal methods.

Source page: https://510kreport.com/device/K983045
Methodology: https://510kreport.com/methodology