Submission Details
| 510(k) Number | K100912 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 01, 2010 |
| Decision Date | August 19, 2010 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
Aug 2010
Decision
140d
Days
Class 2
Risk
About This 510(k) Submission
K100912 is an FDA 510(k) clearance for the DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Kirwan Surgical Products, Inc. (Marshfield, US). The FDA issued a Cleared decision on August 19, 2010, 140 days after receiving the submission on April 1, 2010. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.
Device Classification
| Product Code | GXZ — Electrode, Needle |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.1350 |
Manufacturer
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