Electrosurgical Device 510(k) Guides Issued By FDA

The US agency released two final guidance documents with tips on 510(k)s for electrosurgical devices targeting general tissue cutting, coagulation or sealing indications.

FDA finalized two guidance documents Aug. 12 to assist companies in submitting 510(k)s for electrosurgical devices. The first guidance broadly addresses pre-market submission expectations for general surgery electrosurgical devices and the second document more specifically targets bipolar electrosurgical vessel sealers.

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