Insulin Syringe
by Jiangsu Micsafe Medical Technology Co., Ltd
510(k) K202570
Insulin Syringe is a Class II device made by Jiangsu Micsafe Medical Technology Co., Ltd, cleared under FDA 510(k) K202570 on 2 Jul 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202570 | Date2 Jul 2021 | StatusActive |
Official records
- FDA 510(k) database K202570
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MEG
- FDA applicant
- Jiangsu Micsafe Medical Technology Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K202570
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CoreCare | Insulin Syringe, double cap 0.3ml, 31GX5/16'' | 00850091070136 | On the market | |
| CoreCare | Insulin Syringe, double cap 0.5ml, 31GX5/16'' | 00850091070112 | On the market | |
| CoreCare | Insulin Syringe, double cap 1ml, 31GX5/16'' | 00850091070099 | On the market | |
| CoreCare | Insulin Syringe, double cap 0.5ml, 31GX5/16'' | 00850091070235 | On the market | |
| CoreCare | Insulin Syringe, double cap 0.3ml, 31GX5/16'' | 00850091070280 | On the market | |
| CoreCare | Insulin Syringe, double cap 1ml, 31GX5/16'' | 00850091070273 | On the market | |
| CoreCare | Insulin Syringe, double cap, 1ml,30GX5/16'' | 00850091070051 | On the market | |
| CoreCare | Insulin Syringe, double cap, 0.5ml, 30GX5/16'' | 00850091070068 | On the market | |
| CoreCare | Insulin Syringe, double cap, 0.3ml, 30GX5/16'' | 00850091070037 | On the market | |
| CoreCare | Insulin Syringe, double cap, 1ml,30GX5/16'' | 00850091070259 | On the market | |
| CoreCare | Insulin Syringe, double cap, 0.3ml, 30GX5/16'' | 00850091070266 | On the market | |
| CoreCare | Insulin Syringe, double cap, 0.5ml, 30GX5/16'' | 00850091070013 | On the market | |
| micsafe 1 | 1 | 06971911296551 | On the market | |
| micsafe 1 | 1 | 06971911296568 | On the market | |
| micsafe 1 | 1 | 06971911296520 | On the market | |
| RELI INSY27G051-S1ML | INSY27G051-S1ML / INSY27G051-S1ML | 00386120012940 | Needle Gauge 27 G; Length 0.5 in; Total Volume 1 mL | On the market |
| RELI INSY28G051-S.5ML | INSY28G051-S.5ML / INSY28G051-S.5ML | 00386120012957 | Needle Gauge 28 G; Length 0.5 in; Total Volume 0.5 mL | On the market |
| RELI INSY28G051-S1ML | INSY28G051-S1ML / INSY28G051-S1ML | 00386120012964 | Needle Gauge 28 G; Length 0.5 in; Total Volume 1 mL | On the market |
| RELI INSY28G101-S1ML | INSY28G101-S1ML / INSY28G101-S1ML | 00386120012971 | Needle Gauge 28 G; Length 1 in; Total Volume 1 mL | On the market |
| RELI INSY29G051-S.3ML | INSY29G051-S.3ML / INSY29G051-S.3ML | 00386120012759 | Needle Gauge 29 G; Length 0.5 in; Total Volume 0.3 mL | On the market |
| RELI INSY29G051-S.5ML | INSY29G051-S.5ML / INSY29G051-S.5ML | 00386120012766 | Needle Gauge 29 G; Length 0.5 in; Total Volume 0.5 mL | On the market |
| RELI INSY29G051-S1ML | INSY29G051-S1ML / INSY29G051-S1ML | 00386120012773 | Needle Gauge 29 G; Length 0.5 in; Total Volume 1 mL | On the market |
| RELI INSY30G051-S.3ML | INSY30G051-S.3ML / INSY30G051-S.3ML | 00386120012780 | Needle Gauge 30 G; Length 0.5 in; Total Volume 0.3 mL | On the market |
| RELI INSY30G051-S.5ML | INSY30G051-S.5ML / INSY30G051-S.5ML | 00386120012797 | Needle Gauge 30 G; Length 0.5 in; Total Volume 0.5 mL | On the market |
| RELI INSY30G18751-S.5ML | INSY30G18751-S.5ML / INSY30G18751-S.5ML | 00386120012803 | Needle Gauge 30 G; Length 0.1875 in; Total Volume 0.5 mL | On the market |
| RELI INSY30G18751-S1ML | INSY30G18751-S1ML / INSY30G18751-S1ML | 00386120012810 | Needle Gauge 30 G; Length 0.1875 in; Total Volume 1 mL | On the market |
| RELI INSY30G31251-S.3ML | INSY30G31251-S.3ML / INSY30G31251-S.3ML | 00386120012827 | Needle Gauge 30 G; Length 0.3125 in; Total Volume 0.3 mL | On the market |
| RELI INSY30G31251-S.5ML | INSY30G31251-S.5ML / INSY30G31251-S.5ML | 00386120012834 | Needle Gauge 30 G; Length 0.3125 in; Total Volume 0.5 mL | On the market |
| RELI INSY30G31251-S1ML | INSY30G31251-S1ML / INSY30G31251-S1ML | 00386120012841 | Needle Gauge 30 G; Length 0.3125 in; Total Volume 1 mL | On the market |
| RELI INSY31G31251-S.3ML | INSY31G31251-S.3ML / INSY31G31251-S.3ML | 00386120012858 | Needle Gauge 31 G; Length 0.3125 in; Total Volume 0.3 mL | On the market |
| RELI INSY31G31251-S.5ML | INSY31G31251-S.5ML / INSY31G31251-S.5ML | 00386120012988 | Needle Gauge 31 G; Length 0.3125 in; Total Volume 0.5 mL | On the market |
| RELI INSY31G31251-S1ML | INSY31G31251-S1ML / INSY31G31251-S1ML | 00386120012995 | Needle Gauge 31 G; Length 0.3125 in; Total Volume 1 mL | On the market |
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