ECHELON ENDOPATH Staple Line Reinforcement

Mesh, Surgical, Absorbable, Staple Line Reinforcement

Ethicon Endo-Surgery LLC

The following data is part of a premarket notification filed by Ethicon Endo-surgery Llc with the FDA for Echelon Endopath Staple Line Reinforcement.

Pre-market Notification Details

Device IDK221343
510k NumberK221343
Device Name:ECHELON ENDOPATH Staple Line Reinforcement
ClassificationMesh, Surgical, Absorbable, Staple Line Reinforcement
Applicant Ethicon Endo-Surgery LLC 475 Calle C Guaynabo,  PR  00696
ContactRubina Dosani
CorrespondentRubina Dosani
Ethicon Endo-Surgery LLC 475 Calle C Guaynabo,  PR  00696
Product CodeOXC  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-09
Decision Date2022-09-16

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