Starion Instruments Power Point Cautery Clamp

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

510(k) Number

K001273 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Starion Instruments Power Point Cautery Grasper/Dissector

  Class II

  FDA 510(k) K002547 Active Cleared 20 Oct 2000

• Cautery Grasper/Dissector

  Class II

  FDA 510(k) K994019 Active Cleared 20 Jan 2000

• Thermal Cautery Probe

  Class II

  FDA 510(k) K050308 Active Cleared 25 Feb 2005

• Cautery Forceps with Footswitch

  Class II

  FDA 510(k) K000250 Active Cleared 7 Mar 2000

• Starion Universal Power Supply

  Class II

  FDA 510(k) K070871 Active Cleared 13 Apr 2007

• Ac Powered Thermal Cautery Unit

  Class II

  FDA 510(k) K000893 Active Cleared 14 Jun 2000

See all devices from Starion Instruments →

• What is the Starion Instruments Power Point Cautery Clamp used for?

  The Starion Instruments Power Point Cautery Clamp is intended to remove tissue and control bleeding by delivering high-frequency electrical current through its clamp mechanism, making it suitable for surgical procedures requiring precise tissue dissection and hemostasis in general and plastic surgery settings.

• Is the Starion Instruments Power Point Cautery Clamp reusable or single-use?

  The device is supplied as a reusable instrument, meaning it can be cleaned, sterilized, and used multiple times according to the manufacturer's reprocessing instructions, rather than being discarded after a single use.

• How does the Starion Instruments Power Point Cautery Clamp achieve its surgical effects?

  The device operates by delivering high-frequency electrical current through its clamp mechanism to cut tissue and coagulate blood vessels simultaneously, enabling precise dissection and hemostasis during surgical procedures.

• What regulatory pathway was used for the Starion Instruments Power Point Cautery Clamp?

  The device received FDA 510(k) clearance under submission number K001273 on June 14, 2000, demonstrating it is substantially equivalent to a legally marketed predicate device, and is classified under product code GEI for electrosurgical cutting and coagulation instruments.