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FDA 510(k) Application Details - K193272
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K193272
Device Name
Laparoscope, General & Plastic Surgery
Applicant
Guangzhou TK Medical Instrument Co., Ltd.
A601, Guangzhou International Business Incubator,
Guangzhou Science Park
Guangzhou 510663 CN
Other 510(k) Applications for this Company
Contact
Tracy Weng
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/26/2019
Decision Date
07/09/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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