Ultrasonic Surgical System— 510(k) K233036
Substantially EquivalentHunan Handlike Minimally Invasive Surgery Co., Ltd.
FDA 510(k) clearance K233036 for Ultrasonic Surgical System, Substantially Equivalent on 2024-06-18. Applicant: Hunan Handlike Minimally Invasive Surgery Co., Ltd..
Clearance details
- Applicant
- Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- Product code
- Code LFL
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changsha, CN
Adverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
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.