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510(k) K210934

Sphincterotome / short-wire compatible, Sterile Sphincterotome by Micro-Tech (Nanjing) Co., Ltd. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2021
Date Received
March 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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