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510(k) K232450

Disposable Hemostatic Clips by Zhejiang Soudon Medical Technology Co., Ltd. — Product Code PKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2024
Date Received
August 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Metal Clip For The Gi Tract
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type

Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.

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