# K092981: Panpac Vaginal Pessary

- Pathway: 510(k) (Traditional)
- Applicant: Panpac Medical Corporation
- Decided: Jul 22, 2010 after 297 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132313: Pessary (2014), 3 descendants of its own
- K190277: ProVate Vaginal Support (2019), 1 descendant of its own
- K253698: Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes (2026), 0 descendants of its own
- K232677: Reia pessary (2024), 0 descendants of its own
- K231786: Gynethotics™ Pessary (2024), 0 descendants of its own

## Indications for use
Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele, rectocele as well as stress urinary incontinence in women.

Source page: https://510kreport.com/device/K092981
Methodology: https://510kreport.com/methodology