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510(k) K221252

Device
Scivita 4KINSIGHT ICG Imaging System
Applicant
Scivita Medical Technology Co., Ltd.
510(k) number
K221252
Product code
GCJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-13
Date received
2022-05-02
Regulation
876.1500
Classification name
Laparoscope, General & Plastic Surgery
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ruqin Wu
Address
#8, Zhong Tian Xiang, Suzhou Industrial Park Suzhou CN 215000 215000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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