510(k) K172758

Rotatable Snares, Non-Rotatable Snares by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Product Code FDI

K172758 is an FDA 510(k) premarket notification submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. for the device "Rotatable Snares, Non-Rotatable Snares". The FDA issued a decision of Substantially Equivalent on March 7, 2018. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Zhejiang Chuangxiang Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2018
Date Received
September 13, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type