AccuSert Needle Inserter
FDA 510(k) K213429 · Emed Technologies Corporation
510(k) numberK213429
Submission
- Device name
- AccuSert Needle Inserter
- Applicant
- Emed Technologies Corporation
El Dorado Hills, CA, US - Received
- October 21, 2021
- Decision date
- October 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KZH – Introducer, Syringe Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6920
- Specialty
- General Hospital
Other 510(k)s with product code KZH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243232 | GripMateKZH · Traditional | Synthon Hispania S.L. | 12/02/2024SE |
| K163400 | Orbit InserterKZH · Traditional | Ypsomed AG | 07/26/2017SE |
| K160860 | MiniMed Quick-serterKZH · Traditional | Medtronic Minimed | 09/22/2016SE |
| K141384 | Whisperject AutoinjectorKZH · Abbreviated | Scandinavian Health Limited | 09/12/2014SE |
| K124026 | Lobster Auto-InjectorKZH · Traditional | Scandinavian Health Limited | 09/13/2013SE |
| K122837 | Autoject 2 for Glassy SyringeKZH · Special | Owen Mumford, Ltd. | 10/15/2012SE |
| K111467 | Flexi-Q DV and DVR Auto-InjectorsKZH · Traditional | Elcam Medical Acal | 02/09/2012SE |
| K082587 | Auto-Safety INJECTOR-2 (ASI-2)KZH · Traditional | Medical House Products Limited | 10/02/2008SE |
| K073476 | Compact Auto-Safety Injector (Casi)KZH · Traditional | Medical House (Asi) Limited | 03/07/2008SE |
| K062339 | Dermotherap GunKZH · Traditional | Dermoequipos S.R.L. | 02/05/2007SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50)PKP · Traditional | 12/22/2025SE |
| K240148 | SCIg60 Infusion SystemPKP · Special | 02/16/2024SE |
| K230883 | VersaPump Infusion SystemPKP · Traditional | 11/28/2023SE |
| K222087 | SCIg60 Infusion SystemPKP · Traditional | 10/13/2022SE |
| K173783 | SCIg60 Infusion SystemPKP · Traditional | 12/14/2018SE |
| K161906 | SCIg60 InfuserPKP · Traditional | 12/01/2016SE |
| K142319 | SCIg60 Infuser, InfusetPKP · Traditional | 05/14/2015SE |
| K140133 | Infuset Flow Control Extension SetFPA · Traditional | 05/15/2014SE |
| K140131 | Sub-Q Subcutaneous Tissue Infusion SetFPA · Special | 04/03/2014SE |
| K123729 | Versarate Flow Rate ControlerFPA · Traditional | 12/21/2012SE |
Questions and answers
When was AccuSert Needle Inserter cleared by the FDA?
AccuSert Needle Inserter (K213429) received a 510(k) decision of Substantially Equivalent on October 20, 2022, 364 days after the submission was received.
What is the product code of K213429?
The FDA product code is KZH – Introducer, Syringe Needle, a Class II (moderate risk) device regulated under 21 CFR 880.6920.