# K173351: Panpac Flexi Shelf Pessary

- Pathway: 510(k) (Abbreviated)
- Applicant: Panpac Medical Corporation
- Decided: Oct 31, 2018 after 371 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K231786: Gynethotics™ Pessary (2024), 0 descendants of its own

## Indications for use
The Flexi Shelf Pessary is indicated for use as a removable structure placed in the vagina for the support of a second to third degree prolapse or procidentia.

Source page: https://510kreport.com/device/K173351
Methodology: https://510kreport.com/methodology