The following data is part of a premarket notification filed by A.m. Surgical, Inc. with the FDA for Pegasus System.
| Device ID | K191345 |
| 510k Number | K191345 |
| Device Name: | Pegasus System |
| Classification | Arthroscope |
| Applicant | A.M. Surgical, Inc. 285 Middle Country Road, Suite 206 Smithtown, NY 11787 |
| Contact | Vincent Pascale |
| Correspondent | Vincent Pascale A.M. Surgical, Inc. 285 Middle Country Road, Suite 206 Smithtown, NY 11787 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-20 |
| Decision Date | 2019-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857915007415 | K191345 | 000 |
| 00857915007408 | K191345 | 000 |