Microwave Tissue Coagulation System (MTCS)
by Foundry Newco X, Inc. 510(k)
Active
510(k) K072870
Overview
The Microwave Tissue Coagulation System (MTCS) is a Class II medical device classified under System, Ablation, Microwave and Accessories, designed for the coagulation of soft tissue. It employs microwave energy to achieve controlled tissue heating and sealing, aiding in surgical procedures requiring precise tissue management.
The MTCS is supplied as a reusable system with multiple accessory components, each identified by unique reference codes (e.g., 1000523114, 1721676). It is regulated under 21 CFR 878.4400 and holds FDA 510(k) clearance (K072870) with a decision of Substantially Equivalent (SESE). No specific MRI safety or sterility details are provided in the data, though standard surgical precautions apply.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072870 | Date14 Jan 2008 | 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- Withdrawn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
- NEY
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Microwave Tissue Coagulation System (MTCS) intended for?
The MTCS is designed for the coagulation of soft tissue using microwave energy to achieve controlled tissue heating and sealing, aiding in surgical procedures requiring precise tissue management.
How is the MTCS supplied and what components does it include?
The MTCS is supplied as a reusable system with multiple accessory components, each identified by unique reference codes such as 1000523114 and 1721676, among others listed in the openfda field.
Is the MTCS a single-use or reusable device?
The MTCS is supplied as a reusable system, meaning the main unit and its accessory components are designed for multiple uses following appropriate cleaning and reprocessing procedures.
What regulatory pathway was used for the MTCS and what is its classification?
The MTCS received FDA 510(k) clearance (K072870) with a decision of Substantially Equivalent (SESE) and is classified as a Class II medical device under regulation 21 CFR 878.4400.
What medical specialties is the MTCS associated with based on its regulatory filing?
The MTCS is associated with General and Plastic Surgery specialties, as indicated in the advisory committee and medical specialty description fields of its FDA 510(k) submission.