# K243382: RZ Resectoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Rz Medizintechnik GmbH
- Decided: Jun 3, 2025 after 215 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 K040390 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173070: HSW Resection Instruments, Henke-Sass, Wolf GmbH (2018) Summary page 6.

## Indications for use
The resectoscope system devices are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and gynecological electrosurgical procedures.

Source page: https://510kreport.com/device/K243382
Methodology: https://510kreport.com/methodology