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510(k) K243568

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord by Wilson-Cook Medical, Inc. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2025
Date Received
November 18, 2024
Clearance Type
Special
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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  • K200972 — Hemospray Endoscopic Hemostat (June 10, 2020)
  • K200247 — Fusion Quattro Extraction Balloon (February 27, 2020)
  • K192339 — TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord (January 30, 2020)
  • K193344 — Tri-Ex Extraction Balloon with Multiple Sizing (December 13, 2019)
  • K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (November 14, 2019)
  • K191048 — AcuSnare Polypectomy Snare - Duckbill (July 18, 2019)

Other clearances for product code KNS

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  • 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)