The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Sovereign Mini.
| Device ID | K123102 |
| 510k Number | K123102 |
| Device Name: | SOVEREIGN MINI |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Denise Adams |
| Correspondent | Denise Adams AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-02 |
| Decision Date | 2013-01-03 |
| Summary: | summary |