# K213783: Apyx

- Pathway: 510(k) (Traditional)
- Applicant: Escala Medical
- Decided: Apr 5, 2022 after 123 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: 3 generations back to K042603 (2004). 3 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K160569: NeuGuide, Pop Medical Solutions (2016) Summary page 4.

## Most influential descendants
- K230730: Apyx (2023), 1 descendant of its own
- K260380: Mendit (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K213783
Methodology: https://510kreport.com/methodology