MicroAire® ASP-1021
by MicroAire Surgical Instruments LLC
MicroAire® ASP-1021 is a Class II device made by MicroAire Surgical Instruments LLC, cleared under FDA 510(k) K113128 on 17 Aug 2012 and listed in FDA GUDID since 2 Aug 2016 (UDI-DI 00847399006417), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00847399006417 | Date2 Aug 2016 | StatusListed |
| United States | FDA 510(k) | NumberK113128 | Date17 Aug 2012 | StatusActive |
Official records
- AccessGUDID record 00847399006417
- FDA 510(k) database K113128
Across registries
- FDA 510(k) K113128 decided 17 Aug 2012 Active
- FDA GUDID UDI-DI 00847399006417 listed 2 Aug 2016 Listed
Recalls
-
- Terminated Z-2821-2015
- Terminated Z-2822-2015
There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
Timeline
- Cleared FDA 510(k) K113128
- Recall initiated FDA recalls Z-2821-2015
- Recall initiated FDA recalls Z-2822-2015
- Listed FDA GUDID 00847399006417
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MicroAire®
- Generic name
- Liposuction system
- Model / reference
- ASP-1021
- Primary DI / UDI-DI
- 00847399006417
- 510(k) Number
- FDA product code
- QPB
- GMDN term
- Liposuction system
- Device class
- Class II
- Regulation number
- 878.5040
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Liposuction system.