The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Saphyre Bipolar Ablation Probes.
| Device ID | K031371 |
| 510k Number | K031371 |
| Device Name: | SAPHYRE BIPOLAR ABLATION PROBES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SMITH & NEPHEW, INC. 3700 HAVEN COURT Menlo Park, CA 94025 |
| Contact | Linda Guthrie |
| Correspondent | Linda Guthrie SMITH & NEPHEW, INC. 3700 HAVEN COURT Menlo Park, CA 94025 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-30 |
| Decision Date | 2003-05-23 |
| Summary: | summary |