Microaire Surgical Instruments, LLC - FDA 510(k) Cleared Devices

Microaire Surgical Instruments, LLC designs and manufactures surgical devices for General & Plastic Surgery and related specialties. The company operates with a manufacturing facility in Chesterfield, US, and serves surgeons globally through an established distribution network.

Microaire has received 9 FDA 510(k) clearances from 9 total submissions since 2012. General & Plastic Surgery devices represent the dominant focus, accounting for 78% of regulatory submissions. The company remains active, with its most recent clearance in 2025.

The company's product portfolio centers on power-assisted liposuction systems, tissue fixation implants, and soft tissue release instruments. Notable product lines include the PAL SYNERGY system for liposuction, Endotine multipoint fixation implants for facial procedures, and SmartRelease endoscopic soft tissue release systems. These devices reflect Microaire's specialization in minimally invasive surgical technologies across multiple surgical disciplines.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Ambriel Associates, Inc. as regulatory consultant.