# K122563: Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Sep 19, 2012 after 28 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: 3 generations back to K954050 (1995). 9 ancestors in all.
2 later devices descend 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)
- K091465: Myosure Rod Lens Hysteroscope, Interlace Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K182006: Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths (2018), 1 descendant of its own
- K191281: Omni Hysteroscope, Omni Lok cervical seal (2019), 0 descendants of its own

## Indications for use
The Myosure XL Rod Lens 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/K122563
Methodology: https://510kreport.com/methodology