Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use— 510(k) K183665
Substantially EquivalentJiangsu Micsafe Medical Technology Co., Ltd.
FDA 510(k) clearance K183665 for Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use, Substantially Equivalent on 2019-09-06. Applicant: Jiangsu Micsafe Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Jiangsu Micsafe Medical Technology 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
- Yancheng, CN
Recent devices under product code MEG
view allMore clearances from Jiangsu Micsafe Medical Technology Co., Ltd.
view all- K212019 — Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single
- K202570 — Insulin Syringe, Insulin Syringe with Safety Retractable
- K202205 — Surgical Face Mask
- K181426 — Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
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.