Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use— 510(k) K180417
Substantially EquivalentBerpu Medical Technology Co., Ltd.
FDA 510(k) clearance K180417 for Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use, Substantially Equivalent on 2018-08-09. Applicant: Berpu Medical Technology Co., Ltd..
Clearance details
- Applicant
- Berpu Medical Technology Co., Ltd.
- Product code
- Code MEG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wenzhou, CN
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.