Mixject with Spray Head
FDA 510(k) K122023 · Medimop Medical Projects, Ltd.
510(k) numberK122023
Submission
- Device name
- Mixject with Spray Head
- Applicant
- Medimop Medical Projects, Ltd.
Ra'Anana, IL - Received
- July 11, 2012
- Decision date
- October 4, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
More from Instylla, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160503 | Vented Vial Adapter Transfer Device - 13mmLHI · Special | 05/04/2016SE |
| K140730 | VIAL2BAG Direct ConnectLHI · Traditional | 06/12/2014SE |
| K130179 | MP Vial Adapter 13MMLHI · Traditional | 08/08/2013SE |
| K132040 | Vial Connector 13MM Closed CollarLHI · Special | 07/31/2013SE |
| K072759 | VIAL2BAGLHI · Abbreviated | 12/13/2007SE |
| K072511 | Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MMLHI · Abbreviated | 12/13/2007SE |
| K062482 | Vented Vial Adapter Transfer DeviceLHI · Traditional | 11/03/2006SE |
| K031861 | MIX2VIAL Transfer DeviceLHI · Traditional | 07/29/2003SE |
| K001831 | Needleless Transfer DeviceLHI · Traditional | 07/11/2000SE |
| K001293 | Modification to Mixject Dispensing Pin/With Detachable Vial Holder/With Detachable Vial…LHI · Special | 05/05/2000SE |
Questions and answers
When was Mixject with Spray Head cleared by the FDA?
Mixject with Spray Head (K122023) received a 510(k) decision of Substantially Equivalent on October 4, 2012, 85 days after the submission was received.
What is the product code of K122023?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.