Identifiers
- 510(k) Number
- K210567 FDA 510(k)
- FDA Product Code
- LFL FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ultrasonic Surgical System is a medical device that uses cold pressure technology for cutting and coagulation during surgical procedures. It features uniform tissue pressure, consistent energy output, and efficient cutting and coagulation capabilities.
The system is supplied as a laparoscopic harmonic scalpel that can perform multiple functions including tissue separation, grasping, cutting, and coagulation without requiring instrument changes. The device is manufactured by Miconvey Technologies Co., Ltd. and has received FDA 510K clearance and MDR authorization.
Frequently asked questions
What is the primary function of the Ultrasonic Surgical System?
The Ultrasonic Surgical System uses cold pressure technology for cutting and coagulation during surgical procedures, featuring uniform tissue pressure and consistent energy output.
How is the Ultrasonic Surgical System supplied?
The system is supplied as a laparoscopic harmonic scalpel that can perform multiple functions including tissue separation, grasping, cutting, and coagulation without requiring instrument changes.
What regulatory approvals has the Ultrasonic Surgical System received?
The device has received FDA 510K clearance and MDR authorization, indicating it meets regulatory requirements for safety and performance.
Is the Ultrasonic Surgical System reusable or single-use?
The device data does not specify whether the Ultrasonic Surgical System is designed for single-use or multiple uses, so this information would need to be obtained directly from the manufacturer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Surgical Stapler & Ultrasonic System Manufacturer | Miconvey, Ultrasonic Surgical System Laparoscopic Harmonic Scalpel - Miconvey, Miconvey Product Catalog - Miconvey - PDF Catalogs | Technical ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | U | Active |
| EUDAMED | European Union | MDR | — | U | Active |
| FDA 510(k) | United States | FDA_510K | K210567 | U | Active |
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Manufacturer
- Manufacturer
- Miconvey Technologies Co., Ltd.
Sources (2)
- FDA 510(k) K210567 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026