ASK System— 510(k) K181146
Substantially EquivalentL and K Biomed Corporation Limited
FDA 510(k) clearance K181146 for ASK System, Substantially Equivalent on 2018-08-03. Applicant: L and K Biomed Corporation Limited.
Clearance details
- Applicant
- L and K Biomed Corporation Limited
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yangcheon-Gu, KR
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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.