Disposable Needle Guides and Grids
FDA 510(k) K223689 · Advance Medical Designs, Inc.
510(k) numberK223689
Submission
- Device name
- Disposable Needle Guides and Grids
- Applicant
- Advance Medical Designs, Inc.
Marietta, GA, US - Received
- December 9, 2022
- Decision date
- August 2, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260161 | SmartGuide Disposable Guides and GridsITX · Traditional | UC-CARE , Ltd. | 07/30/2026SE |
| K262474 | ND Needle Guidance SystemITX · Traditional | Accurate Access, LLC | 07/27/2026SE |
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| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | Vitrolife Sweden AB | 08/30/2024SE |
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| K012168 | Advance Medical Designs Fluid PouchKKX · Traditional | 09/18/2001SE |
| K011422 | Surgical DrapesKKX · Traditional | 07/10/2001SE |
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| K925115 | Amd Dentist and Hygienist KitsEKJ · Traditional | 07/05/1994SE |
| K911884 | Advance Pressure Monitor/High Pressure LinesDTL · Traditional | 07/05/1994SE |
| K915301 | Advance Stopcock/High Pressure StopcockDTL · Traditional | 12/11/1992SE |
| K911732 | Advance Disposable Control SyringeIZI · Traditional | 09/16/1991SE |
Questions and answers
When was Disposable Needle Guides and Grids cleared by the FDA?
Disposable Needle Guides and Grids (K223689) received a 510(k) decision of Substantially Equivalent on August 2, 2023, 236 days after the submission was received.
What is the product code of K223689?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.