# K091465: Myosure Rod Lens Hysteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Interlace Medical, Inc.
- Decided: Aug 21, 2009 after 95 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: 2 generations back to K954050 (1995). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941541: HSV Laparoscopy Set, Henke Sass Wolf of America, Inc. (1994) Summary page 1.
- K952186: HSW GMBH Hysteroscopes & Accessories, Henke-Sass, Wolf GmbH (1996) Summary page 1.
- K991563: Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C, Henke Sass Wolf of America, Inc. (1999) Summary page 1.
- K013870: Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow Sheath, Model 8105224, Smith & Nephew, Inc. (2002) Summary page 1.
- K040390: Stryker Urology and Gynecology Hardware System, Stryker Endoscopy (2004) Summary page 1.

## Most influential descendants
- K122563: Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel (2012), 2 descendants of its own
- 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
- K102686: Myosure Rod Lens Scope Seals (2010), 0 descendants of its own

## Indications for use
The MyoSURETM 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/K091465
Methodology: https://510kreport.com/methodology