# K182675: Polygon Resection Device

- Pathway: 510(k) (Traditional)
- Applicant: Polygon Medical, Inc.
- Decided: Jan 4, 2019 after 100 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.
No later device cites it as a predicate yet.
0 of 11 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.

## Indications for use
The Polygon Resection 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/K182675
Methodology: https://510kreport.com/methodology