The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Aura 20 Bipolar Electrosurgical Coagulator, Model 26-2500.
| Device ID | K023482 |
| 510k Number | K023482 |
| Device Name: | AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-17 |
| Decision Date | 2003-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841019112823 | K023482 | 000 |
| 00841019109229 | K023482 | 000 |
| 00841019107065 | K023482 | 000 |
| 00841019106976 | K023482 | 000 |