The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Kirwan Disposable Battery-powered Cautery, Model 41-61xx Series.
| Device ID | K062659 |
| 510k Number | K062659 |
| Device Name: | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES |
| Classification | Unit, Cautery, Thermal, Battery-powered |
| 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 | HQP |
| CFR Regulation Number | 886.4115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-07 |
| Decision Date | 2007-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20841019108646 | K062659 | 000 |
| 20841019107809 | K062659 | 000 |
| 20841019107793 | K062659 | 000 |
| 20841019107786 | K062659 | 000 |
| 20841019107779 | K062659 | 000 |
| 20841019107762 | K062659 | 000 |
| 20841019107755 | K062659 | 000 |
| 20841019107748 | K062659 | 000 |