Company ยท US
MicroAire Surgical Instruments, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2025. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | 8 |
| HRX | Arthroscope | 5 |
| HTY | Pin, Fixation, Smooth | 3 |
| MUU | System, Suction, Lipoplasty | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 2 |
| EMF | Knife, Surgical | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 |
| GET | Motor, Surgical Instrument, Pneumatic Powered | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 |
| HTW | Bit, Drill | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2025 | K243589 | PAL Sterilization Case Microaire Surgical Instruments, LLC | KCT |
| Apr 25, 2025 | K244026 | PAL 7020 Console Microaire Surgical Instruments, LLC | QPB |
| Dec 30, 2024 | K242804 | PAL Aspiration System Microaire Surgical Instruments, LLC | QPB |
| Feb 2, 2023 | K223406 | SmartRelease Endoscopic Soft Tissue Release System Microaire Surgical Instruments | HRX |
| Oct 14, 2022 | K220318 | PAL Infiltration System Microaire Surgical Instruments, LLC | QPB |
| Jun 10, 2022 | K212024 | PAL System Microaire Surgical Instruments, LLC | QPB |
| Jun 24, 2021 | K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System Microaire Surgical Instruments | HRX |
| May 14, 2020 | K192694 | PAL Single-Use Cannulas Microaire Surgical Instruments | QPB |
| Nov 6, 2018 | K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System Microaire Surgical Instruments, LLC | HRX |
| Oct 13, 2017 | K171286 | PAL Multi-Use Cannulas and PAL Manual Wand Microaire Surgical Instruments, LLC | QPB |
| May 22, 2015 | K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack Microaire Surgical Instruments, LLC | MUU |
| Aug 17, 2012 | K113128 | MICROAIRE SURGICAL INSTRUMENTS LLC Microaire Surgical Instruments, LLC | QPB |
| Mar 5, 2002 | K014060 | MICROAIRE 1000E SYSTEM Microaire Surgical Instruments, Inc. | HBE |
| Dec 10, 1998 | K981922 | LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI Microaire Surgical Instruments, Inc. | QPB |
| Nov 26, 1997 | K973268 | MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM Microaire Surgical Instruments, Inc. | BTA |
| Jan 18, 1996 | K955591 | MICROAIRE SMARTDRIVE SYSTEM Microaire Surgical Instruments, Inc. | HWE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2025 | MicroAire Surgical Instruments, LLC Brand Name: SmartRelease ESTR (Endoscopic soft tissue release
system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic
Carpal Tunnel Release) System, Onyx Blade Assembly;
Common Name: SmartR Open, Classified |
EMF | K223406 |
| Jun 26, 2019 | MicroAire Surgical Instruments, LLC SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014 Terminated |
HRX | K912871 |
| May 25, 2018 | MicroAire Surgical Instruments, LLC MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D
The MicroAire Carpal Tunnel Release System is for use in patients diagnosed w Terminated |
HRX | K912871 |
| May 22, 2017 | MicroAire Surgical Instruments, LLC SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE
This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone Terminated |
HTW | None listed |
| Mar 3, 2017 | MicroAire Surgical Instruments, LLC MicroAire K-Wires Terminated |
HTY | K863734 |
| May 27, 2016 | MicroAire Surgical Instruments, LLC Pneumatic Impactor, General Surgery, With Microaire Hose Connector
Professional Use, Medical Industry Terminated |
GET | None listed |
| May 6, 2016 | MicroAire Surgical Instruments, LLC Endotine Transbleph 3.5 (CFD-080-0167) Terminated |
HWC | K042796 |
| Feb 8, 2016 | MicroAire Surgical Instruments, LLC MicroAire PAL Cannula
Product Usage - Power Aspiration Device Terminated |
GEA | None listed |
| Feb 8, 2016 | MicroAire Surgical Instruments, LLC MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula Terminated |
BTA | K973268 |
| Sep 30, 2015 | MicroAire Surgical Instruments, LLC ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump.
Medical use. Terminated |
MUU | K113128 |
| Sep 30, 2015 | MicroAire Surgical Instruments, LLC ASP-1020 LipoTower with Aspiration Pump. Medical use. Terminated |
MUU | K113128 |
| Sep 4, 2013 | MicroAire Surgical Instruments, LLC Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand F Terminated |
HTY | K863764 |
| Sep 4, 2013 | MicroAire Surgical Instruments, LLC Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Terminated |
HTY | K863764 |
| Jun 9, 2012 | MicroAire Surgical Instruments, LLC Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA***
Product Usage:
A fat collection canister intended for use during liposuction proc Terminated |
GCY | None listed |
| Oct 15, 2003 | Microaire Surgical Instruments Pin Driver Coupler, component of MicroAire Drill\Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part ***MicroAire Surgical Instruments Terminated |
None listed | |
| Oct 15, 2003 | Microaire Surgical Instruments Wire Driver Coupler, Model 7100-045, a component of MicroAire Drill/Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part ***MicroAire S Terminated |
None listed |