# K260380: Mendit

- Pathway: 510(k) (Special)
- Applicant: Escala Medical, Ltd.
- Decided: Mar 4, 2026 after 27 days
- Product code: PBQ (Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K042603 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230730: Apyx, Escala Medical (2023) Summary page 5.

## Indications for use
The Mendit device is intended for attaching sutures to ligaments of the pelvic floor.

Source page: https://510kreport.com/device/K260380
Methodology: https://510kreport.com/methodology