Lysonix Aspiration Pump

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K980454 ↗

FDA Product Code

BTA

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Lysonix Lipoplasty Access Port

  Class II

  FDA 510(k) K980763 Active Cleared 28 May 1998

• Lysonix Suction Lipoplasty System

  Class II

  FDA 510(k) K980771 Active Cleared 13 Jul 1998

• Lysonix Irrigation System

  Class I

  FDA 510(k) K974233 Active Cleared 3 Feb 1998

• Lysonix Ttd Delta Scavenger Suction/Aspiration Cannulas Lysonix Infusion Diamond Cannulas

  Class II

  FDA 510(k) K972958 Active Cleared 19 Sep 1997

• Is the Lysonix Aspiration Pump designed for single-use or can it be reused in multiple procedures?

  The Lysonix Aspiration Pump is explicitly described as a reusable medical instrument, meaning it is intended for repeated use across multiple surgical procedures after proper cleaning, disinfection, and maintenance. Unlike single-use devices, it is built for integration into surgical workflows where durability and reliability are priorities.

• What types of surgical settings or specialties is this device primarily intended for?

  While the device is classified under product code BTA (Surgical Suction and Drainage Devices) and regulated for general surgical use, the advisory committee description notes it is associated with General and Plastic Surgery. It is designed for clinical and surgical settings like operating rooms, where maintaining a clear operative field by removing fluids and tissue debris is critical.

• How is the Lysonix Aspiration Pump powered, and can it be used independently or only as part of a larger system?

  The device operates as a portable, powered aspiration pump, meaning it can function independently as a standalone unit. However, it is also designed to integrate with other surgical systems, such as the Lysonix 2000 Ultrasonic Surgical System, allowing flexibility in operative workstation setups depending on clinical needs.

• Are there any specific storage requirements or considerations for the Lysonix Aspiration Pump?

  The provided data does not specify sterility requirements or storage conditions for the Lysonix Aspiration Pump. Since it is reusable, proper cleaning, disinfection, and maintenance protocols (as outlined by the manufacturer) will be essential to ensure safe reuse. Clinicians should follow the manufacturer’s guidelines for storage to prevent contamination or damage, though no details on environmental constraints (e.g., temperature, humidity) are included.

• What regulatory pathway was followed for FDA clearance of this device, and what does that imply for its use?

  The Lysonix Aspiration Pump received FDA 510(k) clearance (K980454) under the Traditional 510(k) review pathway, classified as a Class II device. This implies the manufacturer demonstrated substantial equivalence to a legally marketed predicate device, meaning it shares the same intended use and technological characteristics. Clinically, this clearance indicates the device meets FDA safety and effectiveness standards for its intended purpose—removing fluids and tissue debris during surgery—though it does not imply approval for specific surgical specialties beyond general surgical use.