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510(k) K222421

Sphincterotome by Hangzhou AGS MedTech Co., Ltd. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2023
Date Received
August 11, 2022
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 Hangzhou AGS MedTech Co., Ltd.

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  • K213143 — Hemoclip (July 12, 2022)
  • K213578 — Balloon Dilatation Catheter (April 6, 2022)
  • K211787 — Hemoclip (March 3, 2022)
  • K210406 — Bipolar Coagulation Foreceps (October 5, 2021)
  • K201121 — Sphincterotome (February 5, 2021)
  • K202237 — Locking device (December 23, 2020)
  • K201509 — Disposable Stone Extraction basket (December 16, 2020)

Other clearances for product code KNS

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  • K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (November 25, 2025)
  • K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si (October 17, 2025)
  • K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical (October 10, 2025)
  • K251104 — SureTome™ SW Sphincterotome with DomeTip (September 29, 2025)
  • K251226 — Aqua Medical RF Vapor Ablation System (August 8, 2025)
  • K250584 — Rezum System (June 11, 2025)
  • K242774 — SpydrBlade Flex Instrument (PRD-RG1-001) (June 6, 2025)
  • K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) (March 26, 2025)
  • K242192 — Disposable Sphincterotome (February 6, 2025)