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FDA 510(k) Application Details - K222880
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K222880
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
Endolumik Inc.
364 Patteson Dr. #293
Morgantown, WV 26505 US
Other 510(k) Applications for this Company
Contact
Mara McFadden
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/22/2022
Decision Date
03/03/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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