Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)— 510(k) K181426
Substantially EquivalentJiangsu Micsafe Medical Technology Co., Ltd.
FDA 510(k) clearance K181426 for Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL), Substantially Equivalent on 2018-10-11. Applicant: Jiangsu Micsafe Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Jiangsu Micsafe Medical Technology Co., Ltd.
- Product code
- Code PNR
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yancheng, CN
Recent devices under product code PNR
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- K202570 — Insulin Syringe, Insulin Syringe with Safety Retractable
- K202205 — Surgical Face Mask
- K183665 — Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
Adverse events under product code PNR
product code PNR- Other
- 6
- Total
- 6
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.