Topaz Ez Microdebrider Coblation Wand With Integrated Finger Switch

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

510(k) Number

K140521 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What types of procedures is the Topaz Ez Microdebrider Coblation Wand designed for, and how does it differ from traditional electrosurgical tools?

  The Topaz Ez Microdebrider Coblation Wand is specifically designed for arthroscopic and orthopedic procedures where soft tissue removal or reshaping is required. Unlike traditional electrosurgical tools that rely solely on heat to cut or coagulate tissue, this device uses coblation technology, which combines mechanical debridement with plasma-based ablation. This approach minimizes collateral tissue damage and allows for more precise control during minimally invasive surgeries, particularly in delicate joint or soft tissue applications.

• Is the Topaz Ez Microdebrider Coblation Wand reusable, or is it intended for single-use only? How does this affect its sterility?

  The Topaz Ez Microdebrider Coblation Wand is explicitly designed as a single-use device and is supplied sterile by the manufacturer. This ensures patient safety and eliminates the need for reprocessing, which can introduce risks like contamination or device degradation. Single-use also aligns with modern surgical best practices for minimizing infection risks and maintaining device performance.

• What features does the integrated finger switch provide, and how does it enhance the user experience during surgery?

  The integrated finger switch allows the surgeon to activate the wand directly with their finger, providing precise, hands-free control during procedures. This design reduces the need to shift hand positioning or rely on foot pedals, improving ergonomics and workflow efficiency—especially in confined arthroscopic spaces where dexterity is critical. It also enables more intuitive, real-time adjustments during tissue ablation.

• Does the Topaz Ez Microdebrider Coblation Wand require any additional accessories, and if so, what are they?

  Yes, the wand includes saline irrigation tubing as part of its supply to manage fluid dynamics during procedures. This tubing helps maintain visibility and cooling of the electrode tip, which is essential for optimal coblation performance and patient safety. The tubing is integrated into the device’s design, ensuring compatibility without requiring separate attachments.

• How should the Topaz Ez Microdebrider Coblation Wand be stored, and are there any specific handling instructions to maintain its integrity?

  Since the device is sterile and single-use, it should be stored in its original, sealed packaging until ready for use to preserve sterility. The packaging is designed to protect the wand from contamination, moisture, or physical damage. After opening, the wand must be used immediately and disposed of per facility protocols. Avoid exposing it to extreme temperatures or direct sunlight, as these could compromise the electrode or shaft integrity.