The following data is part of a premarket notification filed by Aesculap Inc. with the FDA for Aesculap Caiman 12 Seal And Cut Technology System.
| Device ID | K203461 |
| 510k Number | K203461 |
| Device Name: | Aesculap Caiman 12 Seal And Cut Technology System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Aesculap Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Omunique Luke |
| Correspondent | Omunique Luke Aesculap Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-24 |
| Decision Date | 2020-12-18 |