# K032644: Kolpexin Sphere

- Pathway: 510(k) (Traditional)
- Applicant: Adamed, Ltd.
- Decided: May 28, 2004 after 275 days
- Product code: HHW (Pessary, Vaginal)
- Device class: 2
- Regulation: 21 CFR 884.3575
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) weighted vaginal training aids for the pelvic floor muscle or Kegel exercise: named in the summary without a submission number
- (no number) Gellhorn pessary: named in the summary without a submission number

## Indications for use
The KOLPEXINTM Sphere is a vaginal pessary that is indicated for the conservative management of vaginal prolapse and pelvic floor muscular weakness.

Source page: https://510kreport.com/device/K032644
Methodology: https://510kreport.com/methodology