K013120 is an FDA 510(k) clearance for the PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18. This device is classified as a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II - Special Controls, product code GZB).
Submitted by Medamicus, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 24, 2002, 128 days after receiving the submission on September 18, 2001.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5880.
| 510(k) Number | K013120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2001 |
| Decision Date | January 24, 2002 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZB — Stimulator, Spinal-cord, Implanted (pain Relief) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5880 |