K250327
- 510(k) number
- K250327
- Device name
- OptaBlate Radiofrequency (RF) Generator System
- Applicant
- Stryker Instruments MI · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-04-15
- Date received
- 2025-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250327.pdf
Official FDA record: K250327
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.