FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Insulin Syringe, Insulin Syringe with Safety Retractable
K Number: K202570
·
Decision Jul 2, 2021
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
161
Applicant Total
5
Review Days
301
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Basic Information
- Device Name
- Insulin Syringe, Insulin Syringe with Safety Retractable
- K Number
- K202570
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jiangsu Micsafe Medical Technology Co., Ltd.
- Date Received
- September 4, 2020
- Decision Date
- July 2, 2021
- Product Code
- MEG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MEG | Syringe, Antistick | FDA class 2 | General Hospital |
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Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
FDA 510(k)
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Other Clearances by Jiangsu Micsafe Medical Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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 | Nov 4, 2021 | Substantially Equivalent |
| K202205 | Surgical Face Mask | Mar 9, 2021 | Substantially Equivalent |
| K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use | Sep 6, 2019 | Substantially Equivalent |
| K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | Oct 11, 2018 | Substantially Equivalent |