The Wand
FDA 510(k) K961648 · Spintech, Inc.
510(k) numberK961648
Submission
- Device name
- The Wand
- Applicant
- Spintech, Inc.
Washington, DC, US - Received
- April 29, 1996
- Decision date
- July 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K043322 | Miramatic Safe Syringe SystemEJI · Traditional | Hager Worldwide, Inc. | 07/21/2005SE |
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| 510(k) | Device | Decision |
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| 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 |
| K992404 | The WandFMF · Traditional | 06/06/2000SE |
| K992819 | Wand PlusEJI · Traditional | 05/11/2000SE |
| K955654 | Shortstop Disposable Prophy AngleEFB · Traditional | 02/08/1996SE |
Questions and answers
When was The Wand cleared by the FDA?
The Wand (K961648) received a 510(k) decision of Substantially Equivalent on July 5, 1996, 67 days after the submission was received.
What is the product code of K961648?
The FDA product code is EJI – Syringe, Cartridge, a Class II (moderate risk) device regulated under 21 CFR 872.6770.