K052111 is an FDA 510(k) clearance for the XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382. This device is classified as a Electrode, Needle (Class II - Special Controls, product code GXZ).
Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on August 17, 2005, 13 days after receiving the submission on August 4, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1350.
| 510(k) Number | K052111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2005 |
| Decision Date | August 17, 2005 |
| Days to Decision | 13 days |
| Submission Type | Abbreviated |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXZ — Electrode, Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1350 |