The following data is part of a premarket notification filed by Key Surgical, Inc. with the FDA for Cautery Tip Cleaner.
| Device ID | K151222 |
| 510k Number | K151222 |
| Device Name: | Cautery Tip Cleaner |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KEY SURGICAL, INC. 8101 WALLACE ROAD Eden Prairie, MN 55344 |
| Contact | Amy Yanta |
| Correspondent | Amy Yanta KEY SURGICAL, INC. 8101 WALLACE ROAD Eden Prairie, MN 55344 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-07 |
| Decision Date | 2015-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849771030492 | K151222 | 000 |
| 10849771052897 | K151222 | 000 |