Total clearances
8
2020-05-14 → 2025-06-20
Name variants in FDA filings: Microaire Surgical Instruments / Microaire Surgical Instruments, LLC
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| QPB |
System, Suction, Lipoplasty For Removal |
Class II |
General, Plastic Surgery |
5 |
2025-04-25 |
| HRX |
Arthroscope |
Class II |
Orthopedic |
2 |
2023-02-02 |
| KCT |
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Class II |
General Hospital |
1 |
2025-06-20 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2025-05-07 |
Class II
|
Ongoing |
Z-1975-2025 |
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (End… |
— |
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. |
Filings
All 510(k) clearances (8)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-06-20 |
K243589 |
PAL Sterilization Case |
KCT |
Class II |
General Hospital |
| 2025-04-25 |
K244026 |
PAL 7020 Console |
QPB |
Class II |
General, Plastic Surgery |
| 2024-12-30 |
K242804 |
PAL Aspiration System |
QPB |
Class II |
General, Plastic Surgery |
| 2023-02-02 |
K223406 |
SmartRelease Endoscopic Soft Tissue Release System |
HRX |
Class II |
Orthopedic |
| 2022-10-14 |
K220318 |
PAL Infiltration System |
QPB |
Class II |
General, Plastic Surgery |
| 2022-06-10 |
K212024 |
PAL System |
QPB |
Class II |
General, Plastic Surgery |
| 2021-06-24 |
K211297 |
SMARTRELEASE Endoscopic Soft Tissue Release System |
HRX |
Class II |
Orthopedic |
| 2020-05-14 |
K192694 |
PAL Single-Use Cannulas |
QPB |
Class II |
General, Plastic Surgery |