AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE— 510(k) K141640
Substantially EquivalentShantou Wealy Medical Instrument Co.,Ltd
FDA 510(k) clearance K141640 for AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE, Substantially Equivalent on 2014-11-19. Applicant: Shantou Wealy Medical Instrument Co.,Ltd.
Clearance details
- Applicant
- Shantou Wealy Medical Instrument Co.,Ltd
- Product code
- Code MEG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lafayette, CA, US
Adverse events under product code MEG
product code MEG- Malfunction
- 1,373
- Other
- 1
- Total
- 1,374
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.