Submission Details
| 510(k) Number | K043442 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 14, 2004 |
| Decision Date | May 31, 2005 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
May 2005
Decision
168d
Days
Class 2
Risk
About This 510(k) Submission
K043442 is an FDA 510(k) clearance for the STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE, a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on May 31, 2005, 168 days after receiving the submission on December 14, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4725.
Device Classification
| Product Code | GXI — Probe, Radiofrequency Lesion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4725 |
Manufacturer
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