# K182006: Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Dec 6, 2018 after 132 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: 4 generations back to K954050 (1995). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122563: Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel, Hologic, Inc. (2012) Summary page 4.
- K091465: Myosure Rod Lens Hysteroscope, Interlace Medical, Inc. (2009) Summary page 4.

## Most influential descendants
- K191281: Omni Hysteroscope, Omni Lok cervical seal (2019), 0 descendants of its own

## Indications for use
The Omni Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K182006
Methodology: https://510kreport.com/methodology