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Data / Medical devices / United States / Microaire Surgical Instruments LLC

Microaire Surgical Instruments LLC: FDA-registered device maker in Charlottesville, VA, United States, 21 510(k) clearances

Microaire Surgical Instruments LLC is registered with the FDA (registration 2020601) in Charlottesville, VA, United States. It lists 26 device types. The FDA files 21 510(k) clearances under its listings, the newest dated June 20, 2025. 13 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Microaire Surgical Instruments LLC
FDA registration number
2020601
Address
3590 Grand Forks Blvd, Charlottesville, VA, United States, 22911
Owner or operator
MICROAIRE SURGICAL INSTRUMENTS, LLC (9004658)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 22, 1992
Registered through
2026
Brand names listed
5000 ET Electric Motor, 5020-ASP, 5020 to Aspiration Pump Cable, 5025 Electric Instrument Console, 5130 High Speed Drill Coupler, 5401 Electric Foot Pedal, 7020-ASP, 7020-INF, 7020-PAL and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Manufactureraccessdata.fda.gov
ArthroscopeHRX2Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Battery, Replacement, RechargeableMOQ1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Manufactureraccessdata.fda.gov
Chisel (Osteotome)KDG1Manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentKIJ1Manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Lavage, JetFQH2Manufactureraccessdata.fda.gov
Motor, Surgical Instrument, Pneumatic PoweredGET1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Manufactureraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Manufactureraccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
Stand, InfusionFOX1Manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Suture, Absorbable, SyntheticGAN2Manufactureraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Manufactureraccessdata.fda.gov
System, Suction, LipoplastyMUU2Manufactureraccessdata.fda.gov
System, Suction, Lipoplasty For RemovalQPB2Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 20, 2025K243589PAL Sterilization CaseKCTSubstantially EquivalentMicroaire Surgical Instruments, LLCaccessdata.fda.gov
April 25, 2025K244026PAL 7020 ConsoleQPBSubstantially EquivalentMicroaire Surgical Instruments, LLCaccessdata.fda.gov
December 30, 2024K242804PAL Aspiration SystemQPBSubstantially EquivalentMicroaire Surgical Instruments, LLCaccessdata.fda.gov
February 2, 2023K223406SmartRelease Endoscopic Soft Tissue Release SystemHRXSubstantially EquivalentMicroaire Surgical Instrumentsaccessdata.fda.gov
October 14, 2022K220318PAL Infiltration SystemQPBSubstantially EquivalentMicroaire Surgical Instruments, LLCaccessdata.fda.gov
June 10, 2022K212024PAL SystemQPBSubstantially EquivalentMicroaire Surgical Instruments, LLCaccessdata.fda.gov
June 24, 2021K211297SMARTRELEASE Endoscopic Soft Tissue Release SystemHRXSubstantially EquivalentMicroaire Surgical Instrumentsaccessdata.fda.gov
May 14, 2020K192694PAL Single-Use CannulasQPBSubstantially EquivalentMicroaire Surgical Instrumentsaccessdata.fda.gov
November 6, 2018K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemHRXSubstantially EquivalentMicroaire Surgical Instruments, LLCaccessdata.fda.gov
October 13, 2017K171286PAL Multi-Use Cannulas and PAL Manual WandQPBSubstantially EquivalentMicroaire Surgical Instruments, LLCaccessdata.fda.gov
August 17, 2012K113128MICROAIRE SURGICAL INSTRUMENTS LLCQPBSubstantially EquivalentMicroaire Surgical Instruments, LLCaccessdata.fda.gov
March 18, 2008K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEHRXSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
June 12, 2006K060249ULTRATINE FOREHEADHWCSubstantially EquivalentCoapt Systems, Inc.accessdata.fda.gov
April 19, 2006K060828MODIFICATION TO ENDOTINE RIBBONGAMSubstantially EquivalentCoapt Systems, Inc.accessdata.fda.gov
November 5, 2004K042796ENDOTINE TRANSBLEPH 3.0/3.5 DEVICEHWCSubstantially EquivalentCoapt Systems, Inc.accessdata.fda.gov
September 28, 2004K041835ENDOTINE MIDFACE B 4.5 DEVICEHWCSubstantially EquivalentCoapt Systems, Inc.accessdata.fda.gov
August 27, 2004K042078ENDOTINE FOREHEAD TRIPLE DEVICEHWCSubstantially EquivalentCoapt Systems, Inc.accessdata.fda.gov
October 29, 2003K032119PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUSKCTSubstantially EquivalentParagon Medical, Inc.accessdata.fda.gov
October 23, 2003K032698COAPT ENDOTINE MIDFACE-ST 4.5 DEVICEGAMSubstantially EquivalentCoapt Systems, Inc.accessdata.fda.gov
October 8, 2003K032770ENDOTINE FOREHEAD DEVICEHWCSubstantially EquivalentCoapt Systems, Inc.accessdata.fda.gov
October 20, 1986K863734STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINSHTYSubstantially EquivalentMicro-Aire Surgical Instruments, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
May 7, 202596868Class IIOngoingBrand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKPotential that the blade can unintentionally cut tissue prior to the user deploying the blade.accessdata.fda.gov
June 26, 201983283Class IITerminatedSmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014There was a higher than normal incidence rate of the blade not retracting when tightening.accessdata.fda.gov
April 19, 201880095Class IITerminatedMicroAire 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 with carpal tunnel synThe Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.accessdata.fda.gov
May 22, 201778687Class IITerminatedSST 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 boneOne lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)accessdata.fda.gov
February 21, 201776560Class IITerminatedMicroAire K-WiresMislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).accessdata.fda.gov
May 6, 201674222Class IITerminatedEndotine Transbleph 3.5 (CFD-080-0167)MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).accessdata.fda.gov
March 11, 201673661Class IITerminatedPneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical IndustryMicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.accessdata.fda.gov
February 8, 201673373Class IITerminatedMicroAire PAL Cannula Product Usage - Power Aspiration DeviceMicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.accessdata.fda.gov
February 8, 201673259Class IITerminatedMicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannulaComplaints that the cannula bent/broke during surgery.accessdata.fda.gov
June 12, 201572106Class IITerminatedASP-1020 LipoTower with Aspiration Pump. Medical use.There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.accessdata.fda.gov
August 12, 201366029Class IITerminatedSteinmann 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 Charlottesville, VA A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterilityaccessdata.fda.gov
April 26, 201261853Class IITerminatedLipofilter 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 procedures.Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.accessdata.fda.gov
September 23, 200327301Not yet classifiedTerminatedWire 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 Surgical Instruments,Wiring pin locking mechanism defective, potential to come apart in surgical site.accessdata.fda.gov

Compare with other makers

Updated June 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.