Monopolar Surgical Instruments
by Tnco, Inc.
510(k) K940552
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK940552 | Date5 May 1994 | 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- Withdrawn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 Monopolar Surgical Instruments are classified as monopolar electrosurgical devices, designed for cutting and coagulating tissue during surgical procedures. These instruments deliver electrical current through a single active electrode while the patient serves as the return path, enabling precise tissue manipulation in controlled environments. They are commonly used in general and plastic surgery applications where fine dissection and hemostasis are required.
These instruments are intended for use in sterile surgical settings and are reusable, requiring proper cleaning, sterilization, and maintenance between procedures. They are regulated under FDA 510(k) clearance (K940552) with a product code of GEI, falling under the General, Plastic Surgery advisory committee. Compliance with manufacturer instructions for sterilization and handling is essential to ensure safe and effective use.
Other devices from Tnco, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the Monopolar Surgical Instruments from Tnco, Inc. used for?
These instruments are designed specifically for cutting and coagulating tissue during surgical procedures. By delivering electrical current through a single active electrode—while the patient acts as the return path—they enable precise tissue manipulation, making them ideal for general and plastic surgery where fine dissection and hemostasis are critical. The controlled electrical current allows surgeons to achieve both cutting and sealing of blood vessels in one step, reducing bleeding and improving procedural efficiency.
Are the Monopolar Surgical Instruments single-use or reusable?
These instruments are reusable. After each use, they must undergo thorough cleaning, sterilization, and maintenance to ensure safety and functionality for subsequent procedures. Proper handling and adherence to manufacturer guidelines are essential to prevent contamination and maintain performance.
What sterilization methods are recommended for these instruments?
The manufacturer specifies that these instruments must be sterilized using approved methods suitable for reusable surgical tools. Common techniques include autoclaving (steam sterilization) or chemical sterilization, provided they comply with the manufacturer’s instructions. Sterilization ensures the removal of pathogens and maintains the integrity of the instruments for repeated use in sterile surgical environments.
Which advisory committee reviewed the FDA clearance for these instruments?
The Monopolar Surgical Instruments were reviewed by the General, Plastic Surgery advisory committee under the FDA’s 510(k) clearance process. This committee evaluates devices intended for use in general and plastic surgery, ensuring they meet safety and effectiveness standards before clearance. The clearance number assigned is K940552.
How should these instruments be stored when not in use?
After sterilization, these instruments should be stored in a clean, dry environment to prevent contamination. They should be kept in a dedicated case or storage system designed to protect them from physical damage and exposure to moisture or dust. Proper storage ensures they remain ready for use while maintaining their sterility and functionality until the next procedure.