# K191538: Resectr Tissue Resection Device

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jan 16, 2020 after 220 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: 6 generations back to K953695 (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)
- K173901: MyoSure MANUAL Tissue Removal Device, Hologic, Inc. (2018) Summary page 4.

## Most influential descendants
- K260984: HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) (2026), 0 descendants of its own

## Indications for use
The Resectr Tissue Resection Device is intended for intrauterine use by physicians trained in hysteroscopy to resect and remove tissue, including focal lesions such as endometrial polyps.

Source page: https://510kreport.com/device/K191538
Methodology: https://510kreport.com/methodology