MicroAire Surgical Instruments, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 14
- 510(k) Clearances
- 16
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1975-2025 | Class II | Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alter | May 7, 2025 |
| Z-2222-2019 | Class II | SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 830 | June 26, 2019 |
| Z-2107-2018 | Class II | MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, | April 19, 2018 |
| Z-0412-2018 | Class II | SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intende | May 22, 2017 |
| Z-1407-2017 | Class II | MicroAire K-Wires | February 21, 2017 |
| Z-2294-2016 | Class II | Endotine Transbleph 3.5 (CFD-080-0167) | May 6, 2016 |
| Z-1834-2016 | Class II | Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Ind | March 11, 2016 |
| Z-1323-2016 | Class II | MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula | February 8, 2016 |
| Z-1328-2016 | Class II | MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device | February 8, 2016 |
| Z-2822-2015 | Class II | ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use. | June 12, 2015 |
| Z-2821-2015 | Class II | ASP-1020 LipoTower with Aspiration Pump. Medical use. | June 12, 2015 |
| Z-2158-2013 | Class II | Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouc | August 12, 2013 |
| Z-2159-2013 | Class II | Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pou | August 12, 2013 |
| Z-1792-2012 | Class II | Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, | April 26, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243589 | PAL Sterilization Case | June 20, 2025 |
| K244026 | PAL 7020 Console | April 25, 2025 |
| K242804 | PAL Aspiration System | December 30, 2024 |
| K223406 | SmartRelease Endoscopic Soft Tissue Release System | February 2, 2023 |
| K220318 | PAL Infiltration System | October 14, 2022 |
| K212024 | PAL System | June 10, 2022 |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System | June 24, 2021 |
| K192694 | PAL Single-Use Cannulas | May 14, 2020 |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | November 6, 2018 |
| K171286 | PAL Multi-Use Cannulas and PAL Manual Wand | October 13, 2017 |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | May 22, 2015 |
| K113128 | MICROAIRE SURGICAL INSTRUMENTS LLC | August 17, 2012 |
| K014060 | MICROAIRE 1000E SYSTEM | March 5, 2002 |
| K981922 | LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, | December 10, 1998 |
| K973268 | MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM | November 26, 1997 |
| K955591 | MICROAIRE SMARTDRIVE SYSTEM | January 18, 1996 |