PDG

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4400

Medical specialty

General, Plastic Surgery

Flags

Third-party review eligible

FDA definition

Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.

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