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FDA 510(k) Application Details - K160417
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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510(K) Number
K160417
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant
NxThera, Inc.
7351 Kirkwood Lane N, Suite 138
Maple Grove, MN 55369 US
Other 510(k) Applications for this Company
Contact
J. Robert Paulson
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
KNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/16/2016
Decision Date
03/17/2016
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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