Radiofrequency Generator System, Cura RF Electrode— 510(k) K240758
Substantially EquivalentZhejiang Curaway Medical Technology Co., Ltd.
FDA 510(k) clearance K240758 for Radiofrequency Generator System, Cura RF Electrode, Substantially Equivalent on 2024-12-11. Applicant: Zhejiang Curaway Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhejiang Curaway Medical Technology Co., Ltd.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code GEI
view allMore clearances from Zhejiang Curaway Medical Technology Co., Ltd.
view all- K260517 — Automatic Core Biopsy Instrument
- K244018 — Disposable Biopsy Needle
- K241793 — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
- K242322 — Bone Marrow Biopsy Needle
- K232505 — Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.