Bipolar Forceps Set (Modular)
by Richard Wolf Medical Instruments Corp. 510(k)
Active
510(k) K981321
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981321 | Date7 Jul 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Bipolar Forceps Set (Modular) is a reusable surgical instrument designed for precise tissue manipulation and coagulation during general and plastic surgery procedures. It employs bipolar electrocautery technology to deliver controlled energy for cutting and sealing vascular structures, reducing bleeding and improving surgical precision. The modular design allows for interchangeable components, enhancing versatility for various surgical applications. This device is classified under product code GEI for general and plastic surgery instruments.
This modular forceps set is intended for reusable use in sterile surgical environments, adhering to standard surgical instrument protocols. The system incorporates a click-it fastening technology for intuitive assembly and disassembly, facilitating efficient use in laparoscopic and open surgical procedures. The device is cleared by the FDA under 510(k) number K981321 as substantially equivalent to a predicate device, with no third-party involvement. Storage and handling follow standard surgical instrument guidelines to maintain sterility and functionality.
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Questions
AI-generated answers, 1 Oct 2026
What is the Bipolar Forceps Set (Modular) used for?
This reusable surgical instrument uses bipolar electrocautery technology to deliver controlled energy for cutting and sealing vascular structures during general and plastic surgery. The modular design allows interchangeable components, making it versatile for various surgical applications while minimizing bleeding and improving precision.
How is the modular design of this forceps set beneficial?
The modular design enables interchangeable components, allowing surgeons to adapt the forceps set to different surgical needs without replacing the entire instrument. This enhances flexibility for both laparoscopic and open procedures, ensuring optimal performance across diverse cases.
Is the Bipolar Forceps Set (Modular) intended for single-use or reusable applications?
This device is explicitly designed for reusable use in sterile surgical environments. It follows standard surgical instrument protocols for cleaning, sterilization, and maintenance to ensure safety and functionality over multiple procedures.
What fastening technology does the set use, and why is it important?
The set incorporates click-it fastening technology, which allows for intuitive and secure assembly and disassembly of components. This feature streamlines workflow efficiency, particularly in time-sensitive surgical settings like laparoscopy or open procedures.
How should the Bipolar Forceps Set (Modular) be stored and handled?
Storage and handling must adhere to standard surgical instrument guidelines to preserve sterility and functionality. This includes proper cleaning, drying, and packaging after use, as well as avoiding exposure to contaminants or physical damage that could compromise performance.