Submission Details
| 510(k) Number | K040565 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 2004 |
| Decision Date | July 22, 2004 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
K040565 - PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
(FDA 510(k) Clearance)
Jul 2004
Decision
141d
Days
Class 2
Risk
K040565 is an FDA 510(k) clearance for the PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE, a Generator, Lesion, Radiofrequency (Class II — Special Controls, product code GXD), submitted by Physician Industries, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 22, 2004, 141 days after receiving the submission on March 3, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4400.
Device Classification
| Product Code | GXD — Generator, Lesion, Radiofrequency |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4400 |
Similar Devices — GXD Generator, Lesion, Radiofrequency
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