K-numberK180403
Device nameENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length
ApplicantEthicon Endo-Surgery, LLC
Product codeGEI
Device classClass II
Decision dateMay 23, 2018
DecisionSubstantially Equivalent
Regulation878.4400
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