# K182975: MAKO 7

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: May 21, 2019 after 208 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: 13 generations back to K931154 (1993). 36 ancestors in all.
No later device cites it as a predicate yet.
1 of 37 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160510: MAKO 7, Nvision Medical Corporation (2016) Summary page 5.

## Indications for use
The MAKO 7 is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the fallopian tube for cytological evaluation.

Source page: https://510kreport.com/device/K182975
Methodology: https://510kreport.com/methodology