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Home » FDA Offers Tips for Electrosurgical Device, Vessel Sealer Submissions
FDA Offers Tips for Electrosurgical Device, Vessel Sealer Submissions
Sponsors of 510(k)s for electrosurgical devices and bipolar electrosurgical vessel sealers intended for general surgery should test the biocompatibility of all materials that will come into contact with the patient, a pair of FDA guidances recommend.