K232947
- 510(k) number
- K232947
- Device name
- SIRA RFA Electrosurgical Device
- Applicant
- Innoblative Designs, Inc. IL · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2023-12-12
- Date received
- 2023-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232947.pdf
Official FDA record: K232947
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.