Flexi-Q DV and DVR Auto-Injectors
FDA 510(k) K111467 · Elcam Medical Acal
510(k) numberK111467
Submission
- Device name
- Flexi-Q DV and DVR Auto-Injectors
- Applicant
- Elcam Medical Acal
Mp. Merom Hagalil, IL - Received
- May 26, 2011
- Decision date
- February 9, 2012
- 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 |
| K213429 | AccuSert Needle InserterKZH · Traditional | Emed Technologies Corporation | 10/20/2022SE |
| 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 |
| 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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|---|---|---|
| K231900 | A-TAP (previously called Arthrotap)FMF · Special | 07/25/2023SE |
| K211204 | SafePort(TM) Manifold (or Stopcock)FMG · Traditional | 09/15/2022SE |
| K190489 | Elcam Stopcocks and ManifoldsFMG · Special | 04/23/2019SE |
| K141254 | Elcam Stopcocks and ManifoldsFMG · Special | 07/30/2014SE |
| K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…FMG · Traditional | 05/23/2013SE |
| K120253 | Elcam Vital Signs Wireless System (VSWS)DRG · Traditional | 07/16/2012SE |
| K120624 | Elcam Disposable Integrated Pressure Transducer (Dipt)DRS · Traditional | 06/08/2012SE |
| K111016 | Safeport Manifold (TM) (or Stopcock)FPA · Special | 06/09/2011SE |
| K100425 | Haskal Torque DeviceDQX · Traditional | 06/17/2010SE |
| K082106 | Elcam Antimicrobial Closed Stopcocks (DSS and TSS)FMG · Special | 10/02/2008SE |
Questions and answers
When was Flexi-Q DV and DVR Auto-Injectors cleared by the FDA?
Flexi-Q DV and DVR Auto-Injectors (K111467) received a 510(k) decision of Substantially Equivalent on February 9, 2012, 259 days after the submission was received.
What is the product code of K111467?
The FDA product code is KZH – Introducer, Syringe Needle, a Class II (moderate risk) device regulated under 21 CFR 880.6920.