K223689 is an FDA 510(k) clearance for the Disposable Needle Guides and Grids. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on August 2, 2023, 236 days after receiving the submission on December 9, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K223689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2022 |
| Decision Date | August 02, 2023 |
| Days to Decision | 236 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |