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FDA 510(k) Application Details - K213283
Device Classification Name
Catheter, Urethral
More FDA Info for this Device
510(K) Number
K213283
Device Name
Catheter, Urethral
Applicant
ConvaTec Limited
GDC, First Avenue, Deeside industrial Park
Deeside CH5 2NU GB
Other 510(k) Applications for this Company
Contact
Louise Hollywood
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
GBM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2021
Decision Date
06/22/2022
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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