Berchtold Elektrotom 106 HITT
510(k) K013668
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013668 | Date4 Feb 2002 | 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- Withdrawn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 Berchtold Elektrotom 106 HITT is an electrosurgical cutting and coagulation device designed for soft tissue coagulation. It operates using high-frequency electrical energy to achieve hemostasis during surgical procedures. This device is classified under the product code GEI, which includes electrosurgical cutting and coagulation instruments. It is intended for use in percutaneous, laparoscopic, and intraoperative settings to control bleeding and coagulate tissue.
The Berchtold Elektrotom 106 HITT is supplied as a reusable system comprising a high-frequency energy generator, a syringe pump, and needle applicators. It has received FDA 510(k) clearance under the Traditional pathway, determined to be substantially equivalent to a predicate device. The device is intended for use in general and plastic surgery procedures, adhering to regulatory standards for electrosurgical instruments. No specific sterility or MRI safety information is provided in the available data.
Other devices from Berchtold GmbH & Co. KG
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Berchtold Elektrotom 106 HITT?
The Berchtold Elektrotom 106 HITT is designed specifically for soft tissue coagulation during surgical procedures. It uses high-frequency electrical energy to achieve hemostasis, helping to control bleeding effectively in settings like general and plastic surgery. This makes it ideal for percutaneous, laparoscopic, and intraoperative applications where precise tissue coagulation is required.
How is the Berchtold Elektrotom 106 HITT supplied, and what components does it include?
The Berchtold Elektrotom 106 HITT is supplied as a reusable system, meaning it is intended for repeated use after proper cleaning and maintenance. The system includes a high-frequency energy generator, a syringe pump, and needle applicators. These components work together to deliver controlled electrosurgical energy for coagulation.
Is the Berchtold Elektrotom 106 HITT single-use or reusable?
The Berchtold Elektrotom 106 HITT is explicitly designed as a reusable system. This means it is built to withstand repeated use cycles, provided it is cleaned, maintained, and sterilized according to manufacturer guidelines. Reusability helps reduce waste and costs while maintaining performance for surgical applications.
What types of surgical procedures is the Berchtold Elektrotom 106 HITT intended for?
The device is intended for use in general and plastic surgery procedures. Its design allows it to be utilized in percutaneous (through the skin), laparoscopic (minimally invasive), and intraoperative (during open surgery) settings. This versatility makes it suitable for a range of surgical environments where hemostasis and tissue coagulation are critical.
Does the Berchtold Elektrotom 106 HITT have any specific sterility or MRI safety information?
The available data for the Berchtold Elektrotom 106 HITT does not provide explicit details regarding sterility requirements or MRI safety. Users should follow standard sterilization protocols for reusable electrosurgical devices and consult manufacturer guidelines for safe handling. Additionally, MRI safety considerations should be evaluated based on the specific materials and components used in the device.