The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 And 28-2600.
| Device ID | K052203 |
| 510k Number | K052203 |
| Device Name: | AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 |
| 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 | 2005-08-12 |
| Decision Date | 2005-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841019115510 | K052203 | 000 |
| 00841019102480 | K052203 | 000 |
| 00841019107003 | K052203 | 000 |
| 00841019107027 | K052203 | 000 |
| 00841019107072 | K052203 | 000 |
| 00841019107089 | K052203 | 000 |
| 00841019107096 | K052203 | 000 |
| 00841019107102 | K052203 | 000 |
| 00841019109205 | K052203 | 000 |
| 00841019109212 | K052203 | 000 |
| 00841019109236 | K052203 | 000 |
| 00841019109496 | K052203 | 000 |
| 00841019109502 | K052203 | 000 |
| 00841019112021 | K052203 | 000 |
| 00841019121238 | K052203 | 000 |