American Biosurgical Electrosurgical Monopolar Cable/Cord
510(k) K971540
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971540 | Date14 Aug 1997 | 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- Withdrawn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 American Biosurgical Electrosurgical Monopolar Cable/Cord is a monopolar electrosurgical cable designed as an electrical conduit. It connects an electrosurgical generator to a monopolar surgical instrument, enabling the delivery of high-frequency electrical current for tissue cutting or coagulation. This device falls under the electrosurgical, cutting & coagulation & accessories category (product code GEI) and is classified as a Class II medical device under special controls.
This cable is intended for use in clinical surgical settings by physicians or surgeons. It is supplied as a sterile, single-use device, packaged in high-grade insulating materials to ensure safety and reliability. The device holds an FDA 510(k) clearance (K971540) and is regulated under the General, Plastic Surgery advisory committee. Storage and handling should comply with sterile medical device protocols.
Other devices from American Biosurgical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the American Biosurgical Electrosurgical Monopolar Cable used for?
This cable serves as an electrical conduit between an electrosurgical generator and a monopolar surgical instrument. It delivers high-frequency electrical current to enable controlled tissue cutting or coagulation during surgical procedures. The design ensures safe and reliable transmission of current, which is essential for procedures requiring precision and minimal thermal spread.
Is the American Biosurgical Monopolar Electrosurgical Cable sterile and single-use?
Yes, the cable is supplied as a sterile, single-use device. It is packaged in high-grade insulating materials to maintain sterility and reliability, adhering to strict medical device standards for surgical use. Single-use ensures patient safety by preventing cross-contamination and reducing the risk of device degradation over repeated use.
How should the American Biosurgical Monopolar Electrosurgical Cable be stored?
The cable must be stored according to sterile medical device protocols. This includes keeping it in its original, unopened packaging until ready for use, protecting it from physical damage, and ensuring it remains in a clean, dry environment. Proper storage preserves sterility and functionality, as required for surgical settings.
What regulatory approval does the American Biosurgical Monopolar Electrosurgical Cable hold?
The device holds FDA 510(k) clearance under the product code GEI (electrosurgical, cutting & coagulation & accessories). It was determined to be substantially equivalent to a legally marketed predicate device and is regulated under the General, Plastic Surgery advisory committee. This clearance ensures compliance with U.S. medical device regulations.
Are there different sizes or models of this cable available?
The provided data does not specify multiple sizes or models for this particular cable. However, it is designed as a standard monopolar electrosurgical cable for general surgical use. For specific length or connector variations, it is recommended to consult the manufacturer’s documentation or contact their technical support for precise details.