I/A Handpiece

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

510(k) Number

K896754 ↗

FDA Product Code

HQE

Device Class

Class II

Regulation

21 CFR Part 886.4150

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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See all devices from Advanced Surgical Products, Inc. →

• What types of ophthalmic surgeries is the I/A Handpiece designed for, and how does it function during those procedures?

  The I/A Handpiece is specifically designed for intraocular surgeries, particularly vitrectomy procedures. It functions as a handheld tool to aspirate and cut vitreous humor, allowing surgeons to remove or reshape tissue within the eye. This dual capability—aspiration and cutting—helps clear the vitreous cavity, improve visualization, and facilitate precise surgical interventions.

• Is the I/A Handpiece intended for single-use or reusable applications, and what are the implications for surgical settings?

  The I/A Handpiece is a multi-use, reusable device, meaning it is engineered for sterile surgical environments where proper cleaning, sterilization, and maintenance protocols are followed. This design allows for repeated use across multiple procedures, provided it is handled in compliance with sterile surgical standards to ensure patient safety and device integrity.

• What are the key specifications or variations in models for the I/A Handpiece, and how might they influence surgical planning?

  The I/A Handpiece is listed under FDA product code HQE and appears in multiple FEI (Facility Establishment Identifier) registrations, suggesting it may be available in various configurations or attachments to suit different surgical needs. While exact model variations (e.g., tip sizes, flow rates, or power settings) aren’t detailed here, these differences could influence factors like tissue removal efficiency or precision during vitrectomy. Always verify compatibility with your specific surgical requirements.

• How should the I/A Handpiece be stored to maintain its performance and sterility between uses?

  Since the device is reusable, it must be stored in a clean, dry, and protected environment to prevent contamination or damage. After use, it should undergo proper cleaning and sterilization per manufacturer guidelines before storage. While the data doesn’t specify storage conditions (e.g., temperature, humidity), adherence to standard surgical instrument protocols—such as using sealed, sterile packaging—is critical to preserve functionality and sterility for subsequent procedures.

• What regulatory pathway does the I/A Handpiece follow, and how does this affect its use in clinical settings?

  The I/A Handpiece holds FDA 510(k) clearance (K896754) under the Traditional 510(k) review pathway, classified as substantially equivalent to a predicate device. This means it has undergone FDA evaluation for safety and effectiveness in ophthalmic vitreous aspiration and cutting procedures. Clinicians can rely on this clearance as evidence of regulatory compliance, though always confirm the latest labeling or updates from the manufacturer for specific use instructions or MRI compatibility (if applicable).