Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe— 510(k) K222001
Substantially EquivalentZhejiang Curaway Medical Technology Co., Ltd.
FDA 510(k) clearance K222001 for Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe, Substantially Equivalent on 2023-06-08. Applicant: Zhejiang Curaway Medical Technology Co., Ltd..
Clearance details
- Applicant
- Zhejiang Curaway Medical Technology Co., Ltd.
- Product code
- Code OAB
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Adverse events under product code OAB
product code OAB- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.