K233425
- 510(k) number
- K233425
- Device name
- FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
- Applicant
- Sutter Medizintechnik GmbH DE
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2024-01-25
- Date received
- 2023-10-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K233425.pdf
Official FDA record: K233425
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.