AccuSert Needle Inserter
FDA 510(k) clearance K213429 · decided 2022-10-20
Clearance details
- K-number
- K213429
- Device name
- AccuSert Needle Inserter
- Applicant
- Emed Technologies Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-10-21
- Decision date
- 2022-10-20
- Days to decision
- 364 days
- Clearance type
- Traditional
- Product code
- KZH
- Device class
- 2
- Regulation number
- 880.6920
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- El Dorado Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GripMate (K243232) | Synthon Hispania S.L. | 2024-12-02 |
| Orbit Inserter (K163400) | Ypsomed AG | 2017-07-26 |
| MiniMed Quick-serter (K160860) | Medtronic Minimed | 2016-09-22 |
| WHISPERJECT AUTOINJECTOR (K141384) | Scandinavian Health Limited | 2014-09-12 |
| LOBSTER AUTO-INJECTOR (K124026) | Scandinavian Health Limited | 2013-09-13 |
| AUTOJECT 2 FOR GLASSY SYRINGE (K122837) | Owen Mumford, Ltd. | 2012-10-15 |
| FLEXI-Q DV AND DVR AUTO-INJECTORS (K111467) | Elcam Medical Acal | 2012-02-09 |
| AUTO-SAFETY INJECTOR-2 (ASI-2) (K082587) | Medical House Products Limited | 2008-10-02 |
| COMPACT AUTO-SAFETY INJECTOR (CASI) (K073476) | Medical House (Asi) Limited | 2008-03-07 |
| DERMOTHERAP GUN (K062339) | Dermoequipos S.R.L. | 2007-02-05 |
| ACCU-CHEK LINKASSIST (K063146) | Disetronic Medical Systems AG | 2006-11-27 |
| DAI-R (K060141) | Shl Medical, USA | 2006-06-12 |
Recalls involving this device
No recalls on record reference this clearance.