K022074 is an FDA 510(k) clearance for the SPHERZ. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by I.Z.I. Corp. (Baltimore, US). The FDA issued a Cleared decision on August 13, 2002, 48 days after receiving the submission on June 26, 2002.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K022074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2002 |
| Decision Date | August 13, 2002 |
| Days to Decision | 48 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 |