Myriad Particles
510(k) K200502
Myriad Particles is a device classified as Unclassified made by Aroa Biosurgery Ltd., cleared under FDA 510(k) K200502 on 31 Mar 2021, 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 | NumberK200502 | Date31 Mar 2021 | StatusActive |
Official records
- FDA 510(k) database K200502
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KGN
- FDA applicant
- Aroa Biosurgery , Ltd.
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K200502
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 | |||
|---|---|---|---|---|
| Myriad Morcells™ PW01NA0200 | PW01NA0200 | 09421906017908 | — | On the market |
| Myriad Morcells™ PW01NA0500 | PW01NA0500 | 09421905067911 | Weight 500 Milligram | On the market |
| Myriad Morcells™ PW01NA1000 | PW01NA1000 | 09421905067928 | Weight 1000 Milligram | On the market |
| Myriad Morcells™ PW01NA2000 | PW01NA2000 | 09421906017915 | Weight 2000 Milligram | No longer on the market |
| Myriad Morcells™ PW02NA0050 | PW02NA0050 | 09421906017977 | Weight 50 Milligram | On the market |
| Myriad Morcells™ PW02NA0100 | PW02NA0100 | 09421906017960 | Weight 100 Milligram | On the market |
| Myriad Morcells™ PW02NA0200 | PW02NA0200 | 09421906017953 | Weight 200 Milligram | On the market |
| Myriad Morcells™ PW02NA0500 | PW02NA0500 | 09421906017946 | Weight 500 Milligram | On the market |
| Myriad Morcells™ PW02NA1000 | PW02NA1000 | 09421906017939 | Weight 1000 Milligram | On the market |
| Myriad Morcells™ PW02NA2000 | PW02NA2000 | 09421906017922 | Weight 2000 Milligram | No longer on the market |
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