# K191281: Omni Hysteroscope, Omni Lok cervical seal

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Aug 29, 2019 after 108 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: 5 generations back to K954050 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182006: Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths, Hologic, Inc. (2018) Summary page 4.

## Indications for use
Omni hysteroscope: 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. Omni Lok cervical seal: The Omni Lok cervical seal is used during a hysteroscopic procedure to minimize liquid distention media leakage from the cervix.

Source page: https://510kreport.com/device/K191281
Methodology: https://510kreport.com/methodology