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FDA 510(k) Application Details - K191341
Device Classification Name
Resectoscope
More FDA Info for this Device
510(K) Number
K191341
Device Name
Resectoscope
Applicant
Corinth MedTech, Inc.
1601 S. De Anza Blvd, Suite 200
Cupertino, CA 95014 US
Other 510(k) Applications for this Company
Contact
Sandeep Saboo
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FJL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/20/2019
Decision Date
06/13/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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