# K173901: MyoSure MANUAL Tissue Removal Device

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: May 8, 2018 after 137 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 K953695 (1995). 9 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142029: Myosure Hysteroscopic Tissue Removal System, Hologic, Inc. (2014) Summary page 4.

## Most influential descendants
- K191538: Resectr Tissue Resection Device (2020), 1 descendant of its own
- K260984: HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) (2026), 0 descendants of its own
- K254050: Manual Tissue Removal Device (2026), 0 descendants of its own
- K182675: Polygon Resection Device (2019), 0 descendants of its own

## Indications for use
The MyoSure MANUAL Tissue Removal Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception.

Source page: https://510kreport.com/device/K173901
Methodology: https://510kreport.com/methodology