K243382
- 510(k) number
- K243382
- Device name
- RZ Resectoscope System
- Applicant
- Rz Medizintechnik GmbH DE
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2025-06-03
- Date received
- 2024-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243382.pdf
Official FDA record: K243382
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.