# K160569: NeuGuide

- Pathway: 510(k) (Traditional)
- Applicant: Pop Medical Solutions
- Decided: Jul 6, 2016 after 128 days
- Product code: PBQ (Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K042603 (2004). 2 ancestors in all.
3 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)
- K120831: Anchorsure, Neomedic International S.L. (2012) Summary page 4.

## Most influential descendants
- K213783: Apyx (2022), 2 descendants of its own
- K230730: Apyx (2023), 1 descendant of its own
- K260380: Mendit (2026), 0 descendants of its own

## Recalls of this device
- Dec 13, 2021 · Class II · Z-0556-2022: Certain lots may not have been packaged wth the Channel Tube Limiter.

## Indications for use
NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.

Source page: https://510kreport.com/device/K160569
Methodology: https://510kreport.com/methodology