# K260984: HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)

- Pathway: 510(k) (Traditional)
- Applicant: Axora Medical, Inc.
- Decided: Aug 18, 2026 after 146 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: 7 generations back to K953695 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233500: Benesta Tissue Removal Device, Caldera Medical, Inc. (2023) Summary page 5.
- K191538: Resectr Tissue Resection Device, Boston Scientific Corporation (2020) Summary page 5.

## Indications for use
The HERizon RD5™ Resecting Device is intended for intrauterine use by physicians trained in hysteroscopy to resect and remove tissue such as endometrial polyps.

Source page: https://510kreport.com/device/K260984
Methodology: https://510kreport.com/methodology