Disposable Irrigating/Aspirating Handpiece

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

510(k) Number

K910973 ↗

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 Surgical Technologies, Inc. →

• Is this handpiece intended for use in any specific surgical procedures beyond ophthalmic applications?

  No, this device is specifically designed for ophthalmic vitreous aspiration and cutting procedures, particularly in small-incision cataract surgery and related vitreoretinal applications. Its functionality is tailored for fluid exchange and tissue removal during these surgical interventions, as stated in the description.

• How should this handpiece be prepared for clinical use, and what are the implications of its initial sterility status?

  The handpiece is supplied as a non-sterile, single-use device and must be sterilized prior to use in a clinical setting. This means it cannot be used directly from packaging and requires proper sterilization procedures to ensure safety and efficacy before surgical use.

• What power source does this irrigating/aspirating handpiece use, and are there any environmental restrictions for its operation?

  This device is ac-powered, meaning it requires access to an electrical outlet for operation. Additionally, it is not intended for use in MRI environments, so it should not be used in magnetic resonance imaging settings.

• How is this device regulated by the FDA, and what does its classification mean for its use?

  The device is regulated under FDA 510(k) clearance (K910973) and is classified as Class II, adhering to regulation number 886.4150. This classification indicates it has been determined to be substantially equivalent to a predicate device and requires compliance with specific FDA standards to ensure safety and effectiveness in its intended ophthalmic applications.

• Can this handpiece be reused after a single surgical procedure, or is it strictly for single-use?

  The device is explicitly labeled as single-use, meaning it is designed for one-time use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, functionality, or patient safety.