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510(k) K232825

Disposable Sphincterotome by Jiangsu Vedkang Medical Science and Technology Co., Ltd. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2024
Date Received
September 13, 2023
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

Other clearances by Jiangsu Vedkang Medical Science and Technology Co., Ltd.

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  • K230598 — Stone Extraction Baskets (September 12, 2023)
  • K222146 — Disposable Endoscopic Hemoclip (March 28, 2023)
  • K220089 — Disposable Polyp Snare (September 22, 2022)
  • K213914 — Injection Needle (July 29, 2022)

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