Low Temperature Cautery Fine Tip, Adjustable, Replaceable Tip

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

510(k) Number

K945761 ↗

FDA Product Code

HQP

Device Class

Class II

Regulation

21 CFR Part 886.4115

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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• What is the Low Temperature Cautery Fine Tip designed for?

  This device is specifically engineered for ophthalmic surgical procedures to deliver controlled low-temperature cauterization. Its fine tip and adjustable design enable precise hemostasis in delicate anatomical areas, reducing tissue trauma during delicate interventions like retinal or corneal surgeries.

• How is the Low Temperature Cautery Fine Tip supplied and intended for use?

  The device is supplied sterile and is intended for single-use only. This design minimizes cross-contamination risks and ensures patient safety by eliminating reuse, which could compromise sterility or performance.

• Is the Low Temperature Cautery Fine Tip reusable, and if not, why?

  No, the device is explicitly intended for single-use. The manufacturer has classified it this way to uphold strict sterility protocols and prevent potential degradation of performance or contamination from repeated use in controlled surgical environments.

• What regulatory pathway does this device follow, and what does that mean for clinicians?

  The Low Temperature Cautery Fine Tip follows the FDA 510(k) clearance pathway, with a clearance number of K945761. This means it has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness as a Class II thermal cautery tool for ophthalmic use.

• Are there any special storage requirements for this device?

  While the provided data does not specify detailed storage instructions, the device’s sterile, single-use nature implies it should be stored in a clean, dry environment protected from contamination until use. Clinicians should follow standard sterile instrument handling protocols to maintain integrity until deployment in surgery.