K924348 is an FDA 510(k) clearance for the AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on November 23, 1992, 88 days after receiving the submission on August 27, 1992.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K924348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1992 |
| Decision Date | November 23, 1992 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |