CarePoint Precision 202-2215
CarePoint Precision 202-2215 is a Class II device made by Allison Medical, Inc., cleared under FDA 510(k) K124037 on 12 Sep 2013 and listed in FDA GUDID since 29 Nov 2023 (UDI-DI 00786227222158), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00786227222158 | Date29 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK124037 | Date12 Sep 2013 | StatusActive |
Official records
- AccessGUDID record 00786227222158
- FDA 510(k) database K124037
Across registries
- FDA 510(k) K124037 decided 12 Sep 2013 Active
- FDA GUDID UDI-DI 00786227222158 listed 29 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K124037
- Listed FDA GUDID 00786227222158
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CarePoint Precision
- Generic name
- Hypodermic needle, single-use
- Model / reference
- 202-2215
- Primary DI / UDI-DI
- 00786227222158
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Hypodermic needle, single-use
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
- Size
- Needle Gauge — 22 GaugeLength — 1.5 Inch
Similar devices in this category
Other devices filed under Hypodermic needle, single-use.
- Safety Needle DN1834S by Jiangsu Micsafe Medical Technology Co., Ltd
- Dispensing Needle for Single Use R41840 by Berpu Medical Technology Co., Ltd
- Peribulbar Needle - Atkinson 1425 by Hurricane Medical
- TJ-123 by Kurin, Inc.
- BD Safety-Lok 305902 by Becton, Dickinson and Company
- DJ-223 by Kurin, Inc.
- WellFine® by MEDEXEL CO., LTD.
- TopFine® by MEDEXEL CO., LTD.
- Surguard™3 SG3-2138RB by Terumo Europe NV