Surgitron IEC II

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

510(k) Number

K001253 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Surgitron Units- Electro Surg Syst Gyn Indication

  Class II

  FDA 510(k) K914329 Active Cleared 2 Apr 1992

• Dento-Surge

  Class II

  FDA 510(k) K955176 Active Cleared 15 Apr 1996

• Non-Ablative Wrinkle Treatment Handpiece

  Class II

  FDA 510(k) K102368 Active Cleared 7 Sep 2010

• Medi-Frig Cryosurgical Unit

  Class II

  FDA 510(k) K954703 Active Cleared 8 Feb 1996

• Surgitron

  Class II

  FDA 510(k) K955167 Active Cleared 8 Feb 1996

• Surgitron Model Ffpf-Emc

  Class II

  FDA 510(k) K972072 Active Cleared 19 Jun 1997

See all devices from Ellman Intl., Inc. →

• What types of surgical procedures is the Surgitron IEC II primarily used for, and why is it considered suitable for these applications?

  The Surgitron IEC II is designed for precise tissue cutting and coagulation in general and plastic surgery settings. It uses high-frequency radio waves to generate controlled heat, allowing surgeons to perform delicate procedures with minimal tissue damage. This makes it particularly useful for procedures requiring fine manipulation, such as skin grafts, tumor removals, or cosmetic surgeries where precision and reduced thermal spread are critical.

• Is the Surgitron IEC II intended for single-use or reusable applications, and what does this mean for maintenance and sterilization?

  The Surgitron IEC II is supplied as a reusable medical instrument, meaning it is built to withstand repeated use in sterile surgical environments. This requires adherence to strict cleaning, disinfection, and sterilization protocols to maintain safety and functionality between procedures. Reusability also implies that the device must be properly maintained by trained personnel to ensure long-term performance and compliance with regulatory standards.

• How is the Surgitron IEC II regulated, and what does its classification as a Class II device entail?

  The Surgitron IEC II is classified as a Class II medical device under FDA regulations, indicating it poses moderate risk and requires special controls to ensure safety and effectiveness. Its FDA 510(k) clearance under the Traditional pathway confirms it is substantially equivalent to a pre-existing device (K001253), meaning it meets established performance standards for electrosurgical instruments. This classification ensures it undergoes rigorous manufacturing oversight, performance testing, and labeling requirements to maintain regulatory compliance.

• What does the product code GEI signify for the Surgitron IEC II, and how does it relate to its intended use?

  The product code GEI categorizes the Surgitron IEC II under General and Plastic Surgery electrosurgical devices. This classification reflects its primary application in controlled tissue manipulation, such as cutting and coagulating during surgeries where precision is essential. The code helps regulatory bodies and healthcare providers identify its intended use within specific surgical specialties, ensuring proper handling, training, and procedural integration.