Cosman Coagulator (CC-1) System

• • Terminated Z-2301-2012 FDA Class II ·initiated 1 Aug 2012

  Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.

510(k) Number

K973297 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Radionics Disposable Rf Cannulae (Sc-C, Rfk-Db, Rfk-Ds)

  Class II

  FDA 510(k) K980430 Active Cleared 16 Mar 1998

• Rfg-3CF

  Class II

  FDA 510(k) K965182 Active Cleared 12 Mar 1997

• Radionics Microelectrode Kit

  Class II

  FDA 510(k) K991399 Active Cleared 21 Sep 1999

• Radionics Xdc External Ventricular Catheter

  Class II

  FDA 510(k) K992379 Active Cleared 8 Sep 1999

• Ocular-Biometer 4000

  Class II

  FDA 510(k) K820042 Active Cleared 22 Jul 1982

• Pace-1A Cardiac Stimulator

  Class II

  FDA 510(k) K963579 Active Cleared 8 Nov 1996

See all devices from Radionics, Inc. →

• What types of surgical procedures is the Cosman Coagulator (CC-1) System primarily designed for, and why is it considered adaptable for different cases?

  The Cosman Coagulator (CC-1) System is designed for general and plastic surgery applications, offering precise control over tissue coagulation. Its adaptability comes from four operational modes—manual, timed, automatic temperature, and automatic power—that allow surgeons to adjust parameters like impedance, temperature, power, and current based on the specific surgical needs. This flexibility ensures it can be used across a range of procedures requiring controlled coagulation.

• Is the Cosman Coagulator (CC-1) System intended for single-use or reusable applications, and what does this mean for maintenance?

  The Cosman Coagulator (CC-1) System is explicitly described as a reusable medical device. This means it is built for repeated use in clinical settings, requiring proper cleaning, sterilization, and maintenance between procedures to ensure safety and functionality. Since it’s not single-use, facilities must follow established protocols for reprocessing to comply with regulatory and infection-control standards.

• How does the device’s microprocessor-controlled RF generator differ from traditional electrosurgical tools, and what benefits does this provide in surgery?

  Unlike traditional electrosurgical tools, the Cosman Coagulator (CC-1) System uses a microprocessor-controlled radiofrequency (RF) generator, allowing precise adjustments to coagulation parameters like impedance, temperature, power, and current. This advanced control reduces the risk of excessive tissue damage or unintended effects, enabling surgeons to achieve more consistent and predictable results—particularly valuable in delicate procedures like plastic surgery where precision matters.

• What does the product code GEI indicate about the intended use of the Cosman Coagulator (CC-1) System, and how does this relate to its FDA clearance?

  The product code GEI categorizes the Cosman Coagulator (CC-1) System under General and Plastic Surgery applications within the FDA’s classification system. This classification reflects its intended use for coagulation tasks in those surgical fields. The system received FDA 510(k) clearance (K973297) under this category, confirming it meets regulatory standards for safety and effectiveness as a radiofrequency generator in those specific contexts.