K260984
- 510(k) number
- K260984
- Device name
- HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)
- Applicant
- Axora Medical, Inc. FL · US
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2026-08-18
- Date received
- 2026-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260984.pdf
Official FDA record: K260984
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.