ARC 400
by Bowa-Electronics GmbH & Co. KG 510(k)
Active
510(k) K193591
Overview
The ARC 400 is a surgical electrocautery device designed for cutting and coagulating tissue during general and plastic surgery procedures. Classified under product code GEI, it delivers controlled electrical energy to achieve precise tissue effects, reducing bleeding and facilitating surgical precision.
Supplied sterile and intended for single-use, the ARC 400 is regulated under FDA 510(k) clearance (K193591) as substantially equivalent to existing devices. It is manufactured by Bowa-Electronics GmbH & Co. KG, based in Gomaringen, Germany, and must be used in accordance with its approved indications as outlined in the regulatory submission. No MRI safety information or reusable variants are specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193591 | Date2 Apr 2020 | 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- Withdrawn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 is the ARC 400 surgical electrocautery device used for?
The ARC 400 is designed specifically for cutting and coagulating tissue during general and plastic surgery procedures. By delivering controlled electrical energy, it helps minimize bleeding and enhances surgical precision, making it ideal for procedures where tissue management is critical.
Is the ARC 400 device sterile and single-use?
Yes, the ARC 400 is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the device’s performance for one surgical procedure.
What regulatory approval does the ARC 400 hold?
The ARC 400 has received FDA 510(k) clearance under the designation K193591, with a decision of substantial equivalence to existing devices. This approval confirms its compliance with U.S. regulatory standards for electrocautery devices in general and plastic surgery.
Does the ARC 400 have any reusable variants or MRI safety information?
No, the ARC 400 is not intended for reuse, and there is no specified MRI safety information provided for this device. It is strictly a single-use product, as outlined in its regulatory submission.
Who manufactures the ARC 400, and where is it based?
The ARC 400 is manufactured by Bowa-Electronics GmbH & Co. KG, a company based in Gomaringen, Germany. The manufacturer’s address is Heinrich-Hertz-Strasse 4-10, 72810 Gomaringen.