Class Class II
RZ Resectoscope System (K243382)
Description
RZ Resectoscope System by Rz Medizintechnik GmbH, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243382
Clearance Date2025-06-03
Clearance TypeTraditional
Product CodeHIH
Regulation Number884.1690
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243382
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. RZ Resectoscope System (K243382) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243383 | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | 2025 |
| K173070 | HSW Resection Instruments | Henke-Sass, Wolf GmbH | 2018 |
Trace the full predicate network for K243382
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.