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FDA 510(k) Application Details - K121370
Device Classification Name
Pneumoperitoneum Needle
More FDA Info for this Device
510(K) Number
K121370
Device Name
Pneumoperitoneum Needle
Applicant
VECTEC
2995 STEVEN MARTIN DR.
FAIRFAX, VA 22031 US
Other 510(k) Applications for this Company
Contact
Diane Horwitz
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FHO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/07/2012
Decision Date
08/02/2013
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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