MicroAire® 81151
by MicroAire Surgical Instruments LLC
MicroAire® 81151 is a Class II device made by MicroAire Surgical Instruments LLC, cleared under FDA 510(k) K223406 on 2 Feb 2023 and listed in FDA GUDID since 17 Mar 2023 (UDI-DI 00847399017277), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00847399017277 | Date17 Mar 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223406 | Date2 Feb 2023 | StatusActive |
Official records
- AccessGUDID record 00847399017277
- FDA 510(k) database K223406
Across registries
- FDA 510(k) K223406 decided 2 Feb 2023 Active
- FDA GUDID UDI-DI 00847399017277 listed 17 Mar 2023 Listed
Recalls
-
- Ongoing Z-1975-2025
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Timeline
- Cleared FDA 510(k) K223406
- Listed FDA GUDID 00847399017277
- Recall initiated FDA recalls Z-1975-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MicroAire®
- Generic name
- Light source adaptor
- Model / reference
- 81151
- Primary DI / UDI-DI
- 00847399017277
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Light source adaptor
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
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