Sharplan Model Ultra Ultrasonic Surg Aspirator

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K913848 ↗

FDA Product Code

MGI

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Sharplan Model 1050 Sealed-Off CO2 Surgical Laser

  Class II

  FDA 510(k) K890287 Active Cleared 12 Apr 1989

• Sharplan Model 1080S CO2 Surgical Laser

  Class II

  FDA 510(k) K933918 Active Cleared 25 Aug 1994

• Sharplan Model 750 Remote Control Unit (Rcu)

  Class II

  FDA 510(k) K890286 Active Cleared 5 Apr 1989

• Sharplan Nd:yag Lasers for ENT and Neck Surgery

  Class II

  FDA 510(k) K900345 Active Cleared 10 Apr 1990

• Sharplan CO2 Surg. Laser, Mo. 1039 Surgicenter 40

  Class II

  FDA 510(k) K921146 Active Cleared 8 Jun 1992

• Sharplan Nd:yag Surgical Laser, Model 3060 Sharplaser 60

  Class II

  FDA 510(k) K926543 Active Cleared 9 Mar 1994

See all devices from Sharplan Lasers, Inc. →

• What types of surgical procedures is the Sharplan Model Ultra Ultrasonic Surgical Aspirator commonly used for?

  The Sharplan Model Ultra Ultrasonic Surgical Aspirator is primarily designed for procedures requiring precise tissue removal and fluid aspiration, such as orthopedic and neurosurgical surgeries. Its ultrasonic energy helps break down and evacuate soft tissue, bone, and debris, making it suitable for minimally invasive techniques in these specialties.

• Is the Sharplan Model Ultra Ultrasonic Surgical Aspirator single-use or reusable, and what does that mean for maintenance?

  The device is supplied as a reusable medical instrument, meaning it is intended for repeated use in controlled surgical environments after proper cleaning, sterilization, and maintenance. To ensure functionality and sterility, storage and maintenance must strictly follow the manufacturer’s guidelines, as outlined in the device’s instructions.

• How should the Sharplan Model Ultra Ultrasonic Surgical Aspirator be stored to maintain its performance?

  Since this is a reusable device, it must be stored in a clean, dry environment and handled according to Sharplan Lasers’ maintenance protocols to preserve sterility and functionality. Improper storage could compromise its performance or safety, so adherence to the manufacturer’s recommendations is critical.

• Can this device be used in an MRI environment, and why or why not?

  No, the Sharplan Model Ultra Ultrasonic Surgical Aspirator is not classified as MRI-safe or MRI-conditional, meaning it should not be used in an MRI environment. Its operation could interfere with MRI systems or pose risks to patients and staff, so strict adherence to non-MRI settings is required.

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

  The device received FDA clearance through a Traditional 510(k) pathway (K913848) and was determined to be substantially equivalent to a legally marketed predicate. This means its safety and effectiveness were compared to an existing device, and it was authorized for use in controlled surgical settings as described in its labeling, with no third-party certifications beyond regulatory submission.