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FDA 510(k) Application Details - K221452
Device Classification Name
Colonoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K221452
Device Name
Colonoscope And Accessories, Flexible/Rigid
Applicant
Lumendi, LLC
253 Post Road West
Westport, CT 06880 US
Other 510(k) Applications for this Company
Contact
Dennis Daniels
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FDF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/18/2022
Decision Date
02/10/2023
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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