Bissinger Monopolar Forceps and Cables
510(k) K143662
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143662 | Date12 Mar 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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 Bissinger Monopolar Forceps and Cables are electrosurgical instruments designed for monopolar coagulation and cutting procedures. These forceps feature either serrated (anatomical) or toothed (surgical) jaws, enabling precise tissue manipulation while delivering controlled electrical energy through a connected cable. They fall under the category of electrosurgical forceps, intended for use in general and plastic surgery applications. The device integrates with a monopolar electrosurgical unit to facilitate coagulation and dissection during surgical interventions.
These forceps and cables are supplied as a reusable medical device, intended for use in sterile surgical settings. They are compatible with standard monopolar electrosurgical generators and are classified under product code GEI for general and plastic surgery. The device received FDA clearance via a 510(k) submission (K143662) under the Traditional pathway, with a review duration of 79 days. No specific MRI safety or single-use designation is indicated in the regulatory data.
Questions
AI-generated answers, 1 Oct 2026
What are the Bissinger Monopolar Forceps and Cables used for?
The Bissinger Monopolar Forceps and Cables are designed for monopolar electrosurgical procedures, specifically coagulation and cutting. They are engineered to provide controlled electrical energy delivery during surgical interventions, making them suitable for general and plastic surgery applications. The serrated (anatomical) or toothed (surgical) jaws allow for precise tissue manipulation while ensuring effective dissection and sealing of blood vessels.
Are the Bissinger Monopolar Forceps and Cables single-use or reusable?
The Bissinger Monopolar Forceps and Cables are supplied as a reusable medical device. They are intended for use in sterile surgical settings and must be properly cleaned, sterilized, and maintained between procedures to ensure safety and functionality. Reusability is a key feature, allowing for cost-effective use across multiple surgical cases.
What types of jaws do the Bissinger Monopolar Forceps and Cables come with?
These forceps are available with two distinct jaw types: serrated (anatomical) jaws and toothed (surgical) jaws. The serrated jaws are designed for delicate anatomical precision, while the toothed jaws provide a firmer grip for general surgical applications. This versatility allows clinicians to select the appropriate jaw type based on the specific surgical requirements.
Are these forceps compatible with all monopolar electrosurgical units?
The Bissinger Monopolar Forceps and Cables are designed to integrate with standard monopolar electrosurgical generators. While they are intended to be compatible with most widely used systems, it is always recommended to verify compatibility with your specific electrosurgical unit before use. This ensures optimal performance and safety during surgical procedures.
How should the Bissinger Monopolar Forceps and Cables be stored?
These forceps and cables should be stored in a clean, dry environment, protected from moisture, dust, and physical damage. Proper storage involves keeping them in their original packaging or a designated sterile storage container when not in use. If reusable, they must be cleaned, inspected, and sterilized according to established medical device reprocessing protocols before each use to maintain sterility and functionality.