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Black And Black Electrosurgical Cutting And Coagulation Forceps And Electrodes

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072124

by Black & Black Surgical, Inc.

Identifiers

510(k) Number
K072124 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an electrosurgical forceps and electrode set designed for cutting and coagulating tissue during surgical procedures. It operates via monopolar electrosurgery, delivering controlled electrical currents to achieve precise tissue separation and hemostasis. The forceps feature insulated handles and tungsten carbide inserts to enhance coagulation efficiency and safety. Electrodes are interchangeable with the forceps, enabling versatile use across multiple surgical applications.

The forceps and electrodes are reusable medical devices intended for use in operating room settings, adhering to standard surgical aseptic techniques. They are classified under FDA product code GEI and were granted FDA 510(k) clearance under the Traditional pathway, with a decision date of January 18, 2008. No specific sterility or MRI safety information is provided in the data. The device is supplied as a kit, with forceps available in a 7-inch (18 cm) length and a 4000 Jaw configuration, as referenced in specifications.

Frequently asked questions

What is the primary use of the Black & Black Electrosurgical Forceps and Electrodes?

This device is designed for cutting and coagulating tissue during surgical procedures using monopolar electrosurgery. The tungsten carbide inserts in the forceps enhance coagulation efficiency, while the insulated handles improve safety by reducing the risk of unintended electrical discharge. It is intended for use in operating rooms where precise tissue separation and hemostasis are required.

Are the forceps and electrodes reusable or single-use?

The Black & Black Electrosurgical Forceps and Electrodes are reusable medical devices. They must be cleaned, disinfected, and maintained according to standard surgical aseptic techniques to ensure safety and functionality for repeated use. Reusability is common for electrosurgical tools in operating room settings to balance cost and sterility protocols.

What sizes and configurations are available in this kit?

This kit includes forceps with a 7-inch (18 cm) length and a 4000 Jaw configuration. The electrodes are interchangeable with the forceps, allowing versatility across various surgical applications. The 4000 Jaw designation refers to the specific design of the forceps tips, which may influence tissue handling and coagulation performance.

How should the device be stored to maintain its integrity?

Since this is a reusable device, storage should follow manufacturer guidelines for electrosurgical instruments to prevent damage or contamination. Typically, this involves keeping the forceps and electrodes in a clean, dry environment, protected from sharp objects or excessive pressure. If the device is not in use, it should be stored in its original packaging or a designated instrument tray until sterilization or cleaning.

What regulatory pathway was followed for FDA clearance of this device?

The Black & Black Electrosurgical Forceps and Electrodes were cleared through the FDA’s Traditional 510(k) pathway, determined to be substantially equivalent to a legally marketed predicate device. The clearance was granted under product code GEI (General and Plastic Surgery) and reviewed by the Surgical Devices Subcommittee (SU) of the General Hospital Devices Panel. The decision date was January 18, 2008.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Electrosurgical Instruments | Black & Black Surgical, Electrosurgical Instruments | Black & Black Surgical, Black And Black Electrosurgical Cutting And Coagulation Forceps And ..., Black and Black Electrosurgical Cutting and Coagulation Forceps and ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Black & Black Surgical, Inc.

Sources (1)

  • FDA 510(k) K072124 24 fields · synced Oct 1, 2026