Submission Details
| 510(k) Number | K042375 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 01, 2004 |
| Decision Date | October 26, 2004 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
SMK, CX, CXE, RCN
Oct 2004
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
K042375 is an FDA 510(k) clearance for the SMK, CX, CXE, RCN, a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI), submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on October 26, 2004, 55 days after receiving the submission on September 1, 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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