Hironic Obtains US FDA Approval for Universal Electrosurgical Device 'Silkro'
[Asia Economy Reporter Myunghwan Lee] Hyronic announced on the 7th that its universal electrosurgical device SILKRO received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on the 3rd.
The company explained, "510(k) is a program that demonstrates the safety and effectiveness of medical devices before market release," adding, "With this approval, there is no need to obtain premarket approval (PMA) for the product in the United States."
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They also added, "The domestic product similar to this device is named GENTLO."
This content was produced with the assistance of AI translation services.
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