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FDA 510(k) Application Details - K203255
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K203255
Device Name
Laparoscope, General & Plastic Surgery
Applicant
Scivita Medical Technology Co., Ltd.
No. 8, Zhong Tian Xiang, Suzhou Industrial Park, Suzhou,
Jiangsu Prov., China
Suzhou 215000 CN
Other 510(k) Applications for this Company
Contact
Ruqin Wu
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
11/04/2020
Decision Date
02/24/2021
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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