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Thermal Cautery Device Forceps

by Starion Instruments

510(k) K990728

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990728 Date3 Jun 1999ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQP
Device Class
Class II
Regulation
21 CFR Part 886.4115
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Thermal Cautery Device, Forceps, classified under the nomenclature for battery-powered thermal cautery instruments. It is designed to simultaneously cut and coagulate soft tissue during surgical procedures, providing precise control for hemostasis and tissue management. The forceps apply thermal energy to achieve cauterization, reducing bleeding and minimizing tissue trauma. Its primary application is within ophthalmic and general surgical disciplines where controlled tissue manipulation is required.

The Thermal Cautery Device Forceps is a single-use, battery-powered instrument intended for intraoperative use. Supplied sterile and packaged for one-time application, it adheres to FDA 510(k) clearance (K990728) under product code HQP, classified as a Class II device under special controls. No MRI safety or reusable components are specified. Storage requires adherence to manufacturer guidelines for sterile, dry conditions prior to use. Regulatory compliance is governed by 21 CFR 886.4115 and submitted to the Ophthalmic (OP) Advisory Committee.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary use of the Starion Thermal Cautery Forceps?

    The Starion Thermal Cautery Forceps is designed for intraoperative use in ophthalmic and general surgical procedures. It simultaneously cuts and coagulates soft tissue to achieve hemostasis (stop bleeding) and minimize tissue trauma, ensuring precise control during delicate surgical manipulations.

  • Is the Thermal Cautery Forceps reusable or single-use?

    This device is explicitly intended for single-use only. It is supplied sterile and packaged for one-time application, eliminating the need for reprocessing or reuse. This design ensures patient safety and maintains sterility standards.

  • How should the Thermal Cautery Forceps be stored before use?

    The device must be stored in sterile, dry conditions as per the manufacturer’s guidelines. Proper storage preserves sterility and functionality, ensuring it remains ready for use when needed in the operating room.

  • Does the Thermal Cautery Forceps have any MRI safety considerations?

    The manufacturer does not specify MRI safety features for this device. Clinicians should follow standard protocols for non-MRI-safe instruments when operating near MRI equipment to avoid interference or safety risks.

  • What regulatory pathway does the Thermal Cautery Forceps follow?

    The device is cleared under FDA’s 510(k) pathway (K990728) as a Class II medical device under product code HQP. It adheres to special controls and regulatory compliance under 21 CFR 886.4115, with submissions reviewed by the Ophthalmic (OP) Advisory Committee.