The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator Probe, Bipolar Side By Side.
| Device ID | K100912 |
| 510k Number | K100912 |
| Device Name: | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE |
| Classification | Electrode, Needle |
| Applicant | KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DR. Marshfield, MA 02050 |
| Contact | Kevin P Prario |
| Correspondent | Kevin P Prario KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DR. Marshfield, MA 02050 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-01 |
| Decision Date | 2010-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20841019110229 | K100912 | 000 |
| 10841019122447 | K100912 | 000 |
| 10841019122454 | K100912 | 000 |
| 10841019122461 | K100912 | 000 |
| 10841019122478 | K100912 | 000 |
| 10841019122485 | K100912 | 000 |
| 10841019122492 | K100912 | 000 |
| 10841019122508 | K100912 | 000 |
| 10841019122515 | K100912 | 000 |
| 20841019108165 | K100912 | 000 |
| 20841019108172 | K100912 | 000 |
| 20841019108189 | K100912 | 000 |
| 20841019108196 | K100912 | 000 |
| 20841019110205 | K100912 | 000 |
| 20841019110212 | K100912 | 000 |
| 10841019122430 | K100912 | 000 |