Pegasus 1001
Pegasus 1001 is an endoscopic control/video-imaging system (FDA Class II; FDA product code HRX, Arthroscope) made by A.M. Surgical, Inc., cleared under FDA 510(k) K191345 on 17 Jul 2019 and listed in FDA GUDID since 30 Jul 2019 (UDI-DI 00857915007415), 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 | GUDID listing | Number00857915007415 | Date30 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191345 | Date17 Jul 2019 | StatusActive |
Official records
- AccessGUDID record 00857915007415
- FDA 510(k) database K191345
Across registries
- FDA 510(k) K191345 decided 17 Jul 2019 Active
- FDA GUDID UDI-DI 00857915007415 listed 30 Jul 2019 Listed
Timeline
- Cleared FDA 510(k) K191345
- Listed FDA GUDID 00857915007415
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pegasus
- Generic name
- Endoscopic control/video-imaging system
- Model / reference
- 1001
- Primary DI / UDI-DI
- 00857915007415
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Endoscopic control/video-imaging system
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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