Pegasus System
510(k) K191345
Pegasus System is a medical device (FDA Class II; FDA product code HRX, Arthroscope) made by A.M. Surgical, Inc., cleared under FDA 510(k) K191345 on 17 Jul 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191345 | Date17 Jul 2019 | StatusActive |
Official records
- FDA 510(k) database K191345
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K191345
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Pegasus 1000 | 1000 | 00857915007408 | On the market | |
| Pegasus 1001 | 1001 | 00857915007415 | On the market |
Similar devices
Other devices filed under FDA product code HRX (Arthroscope).
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