BOWA Neutral Electrodes
by Bowa-Electronics GmbH & Co. KG 510(k)
Active
510(k) K173877
Overview
The BOWA Neutral Electrodes are disposable dispersive electrodes designed for use with monopolar electrosurgical devices. These electrodes facilitate the safe conduction of high-frequency (HF) current from the surgical instrument to the patient during procedures, ensuring proper grounding and minimizing the risk of tissue damage or burns. They are classified under the category of electrosurgical cutting and coagulation accessories, specifically for general and plastic surgery applications. Constructed for single-use, they adhere to strict safety standards to maintain patient protection during surgical interventions.
Supplied as sterile, single-use devices, the BOWA Neutral Electrodes are intended for use in operating rooms and surgical settings where monopolar electrosurgery is performed. They are classified as Class II medical devices under the FDA’s Special Controls for electrosurgical accessories (product code GEI) and have received FDA 510(k) clearance (K173877). Each electrode is designed for one-time application to prevent contamination and ensure reliability. Storage should follow manufacturer guidelines to preserve sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173877 | Date15 Feb 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from Bowa-Electronics GmbH & Co. KG
Questions
What are the BOWA Neutral Electrodes used for?
The BOWA Neutral Electrodes are designed as disposable dispersive electrodes for monopolar electrosurgical devices. Their primary purpose is to safely conduct high-frequency (HF) current from the surgical instrument to the patient during procedures, ensuring proper grounding. This minimizes the risk of tissue damage or burns, making them essential for safe electrosurgery in operating rooms, particularly in general and plastic surgery applications.
Are the BOWA Neutral Electrodes single-use or reusable?
The BOWA Neutral Electrodes are strictly single-use devices. This design choice prevents contamination and ensures reliability, adhering to strict safety standards for patient protection during surgical interventions. Reuse is not recommended or permitted.
How should the BOWA Neutral Electrodes be stored to maintain sterility?
To preserve sterility and functionality, the BOWA Neutral Electrodes must be stored according to the manufacturer’s guidelines. This typically involves keeping them in their original, sealed packaging until use and avoiding exposure to moisture, extreme temperatures, or physical damage. Proper storage ensures the electrodes remain effective for their intended single-use application.
What regulatory classification and clearance do the BOWA Neutral Electrodes hold?
The BOWA Neutral Electrodes are classified as Class II medical devices under the FDA’s Special Controls for electrosurgical accessories (product code GEI). They have received FDA 510(k) clearance (K173877) and are deemed substantially equivalent to a predicate device, ensuring compliance with regulatory standards for safety and performance.
Can these electrodes be used in any surgical setting?
The BOWA Neutral Electrodes are specifically intended for use in operating rooms and surgical settings where monopolar electrosurgery is performed. While they are versatile for general and plastic surgery applications, they are not designed for use outside controlled surgical environments or with bipolar electrosurgical devices, which require different grounding configurations.