Codman Isocool Bipolar Forceps

• • Terminated Z-2206-2019 FDA Class II ·initiated 19 Jul 2019

  Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected

510(k) Number

K083895 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Codman & Shurtleff, Inc. →

• What types of surgical procedures can the Codman Isocool Bipolar Forceps be used for, and why is this device preferred in those settings?

  The Codman Isocool Bipolar Forceps is designed for use in general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery. It is preferred in these settings because its bipolar design allows for precise cauterization and coagulation of tissue while minimizing damage to surrounding areas. This precision is particularly valuable in delicate procedures like neurosurgery or maxillofacial surgery, where minimizing collateral tissue injury is critical.

• Are the tips of the Codman Isocool Bipolar Forceps reusable, and if not, how are they supplied?

  No, the tips of the Codman Isocool Bipolar Forceps are not reusable—they are sterile, disposable components. The device is supplied with a reusable insulated handle (available in irrigating or non-irrigating variants) paired with these single-use tips, ensuring sterility and reducing cross-contamination between procedures.

• What are the key differences between the irrigating and non-irrigating variants of the Codman Isocool Bipolar Forceps handle?

  The primary difference lies in functionality: the irrigating variant allows for simultaneous irrigation while cauterizing or coagulating tissue, which helps cool the surgical site and reduce charring or smoke. The non-irrigating variant lacks this feature, making it suitable for procedures where irrigation isn’t required. Both variants share the same reusable handle design but cater to different surgical needs.

• How is the Codman Isocool Bipolar Forceps regulated, and what does the FDA’s 510(k) clearance indicate about its safety and effectiveness?

  The Codman Isocool Bipolar Forceps holds FDA 510(k) clearance (K083895) under the General, Plastic Surgery advisory committee classification, indicating it has been determined *substantially equivalent* to a legally marketed predicate device. This clearance suggests that the FDA has reviewed its design, performance, and safety data to confirm it meets regulatory standards for bipolar electrosurgical forceps, ensuring it is as safe and effective as comparable existing devices.