Bipolar Hf Cable
by Richard Wolf Medical Instruments Corp. 510(k)
Active
510(k) K983236
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983236 | Date4 Dec 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- Withdrawn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 HF Cable REF 8108.033 is a High-Frequency Electrosurgical Cable (Product Code: GEI) designed to transmit bipolar high-frequency electrical current. It serves as an electrical conduit between an electrosurgical generator and bipolar surgical instruments, facilitating controlled tissue coagulation and cutting during procedures. This device is classified under the General, Plastic Surgery advisory committee category and is intended for use in surgical settings where precise electrosurgical manipulation is required.
Supplied as a single-use device, the Bipolar HF Cable REF 8108.033 measures 3 meters in length and is constructed of plastic materials. It is intended for use in clinical environments by trained healthcare professionals and has been granted FDA 510(k) clearance under the Traditional pathway (K983236). The device adheres to regulatory standards for electrosurgical cables and is not intended for MRI use. Storage and handling should follow standard sterile or non-sterile medical device protocols as per manufacturer guidelines.
Other devices from Richard Wolf Medical Instruments Corp.
See all devices from Richard Wolf Medical Instruments Corp. →
Questions
AI-generated answers, 1 Oct 2026
What is the Bipolar HF Cable REF 8108.033 used for?
The Bipolar HF Cable REF 8108.033 is designed to transmit bipolar high-frequency electrical current between an electrosurgical generator and surgical instruments. It enables controlled tissue coagulation and cutting during procedures, ensuring precise manipulation in surgical settings where such techniques are required.
How is the Bipolar HF Cable REF 8108.033 supplied and what is its length?
The cable is supplied as a single-use device and measures 3 meters in length. This length ensures flexibility and reach during surgical procedures while maintaining the integrity of the electrosurgical circuit.
Is the Bipolar HF Cable REF 8108.033 sterile and intended for reuse?
The device is not explicitly described as sterile in the provided data, so it should be handled according to standard sterile or non-sterile medical device protocols as per manufacturer guidelines. It is explicitly labeled as a single-use item, meaning it is intended for one-time use only and should not be reused.
Can the Bipolar HF Cable REF 8108.033 be used in MRI environments?
No, the Bipolar HF Cable REF 8108.033 is explicitly stated as not intended for MRI use. This is important to note to avoid potential risks associated with electromagnetic interference or damage to the device in magnetic resonance imaging environments.
What regulatory pathway was followed for the Bipolar HF Cable REF 8108.033?
The device was granted FDA 510(k) clearance under the Traditional pathway, with the clearance number K983236. This pathway involves demonstrating that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness.