Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle— 510(k) K170651
Substantially EquivalentYangzhou Medline Industry, Co., Ltd.
FDA 510(k) clearance K170651 for Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle, Substantially Equivalent on 2017-08-02. Applicant: Yangzhou Medline Industry, Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Yangzhou Medline Industry, Co., Ltd.
- Product code
- Code MEG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yangzhou, CN
Recent devices under product code MEG
view allMore clearances from Yangzhou Medline Industry, Co., Ltd.
view allAdverse 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.