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FDA 510(k) Application Details - K221343
Device Classification Name
More FDA Info for this Device
510(K) Number
K221343
Device Name
ECHELON ENDOPATH Staple Line Reinforcement
Applicant
Ethicon Endo-Surgery LLC
475 Calle C
Guaynabo, PR 00696 US
Other 510(k) Applications for this Company
Contact
Rubina Dosani
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/09/2022
Decision Date
09/16/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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