# K151275: MAKO Device

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Medical
- Decided: Nov 13, 2015 after 184 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931154 (1993). 34 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 37 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132384: U-Scope 8000 System with HSC+Emb Cannula, Endosec Corporation (2014) Summary page 4.

## Most influential descendants
- K160510: MAKO 7 (2016), 1 descendant of its own
- K182975: MAKO 7 (2019), 0 descendants of its own

## Indications for use
The MAKO Device is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the proximal fallopian tube for cytological evaluation.

Source page: https://510kreport.com/device/K151275
Methodology: https://510kreport.com/methodology