The Wand
FDA 510(k) K992404 · Spintech, Inc.
510(k) numberK992404
Submission
- Device name
- The Wand
- Applicant
- Spintech, Inc.
Washington, DC, US - Received
- July 19, 1999
- Decision date
- June 6, 2000
- 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
Other 510(k)s with product code FMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| 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 |
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| K223079 | StageLNH · Special | 10/28/2022SE |
| K212109 | Spin Care Disposable Protective Mask Level 3FXX · Traditional | 11/14/2021SE |
| K210843 | StageLNH · Traditional | 06/29/2021SE |
| K201624 | Spin Care Disposable Protective MaskFXX · Traditional | 03/18/2021SE |
| K173224 | Spin-SwiLNH · Traditional | 02/23/2018SE |
| K023722 | Safetywand Disposable HandpieceEJI · Traditional | 09/02/2003SE |
| K010692 | The Wand Plus Computer Controlled Anesthetic Delivery SystemFMF · Traditional | 06/29/2001SE |
| K992819 | Wand PlusEJI · Traditional | 05/11/2000SE |
| K961648 | The WandEJI · Traditional | 07/05/1996SE |
| K955654 | Shortstop Disposable Prophy AngleEFB · Traditional | 02/08/1996SE |
Questions and answers
When was The Wand cleared by the FDA?
The Wand (K992404) received a 510(k) decision of Substantially Equivalent on June 6, 2000, 323 days after the submission was received.
What is the product code of K992404?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.