Home / 510(k) Clearances / K173673

510(k) K173673

AcuSnare Polypectomy Snare by Wilson-Cook Medical, Inc. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2018
Date Received
November 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Wilson-Cook Medical, Inc.

  • K251104 — SureTome™ SW Sphincterotome with DomeTip (September 29, 2025)
  • K243568 — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (January 17, 2025)
  • K213356 — Entuit PEG, Entuit PEGJ (January 20, 2022)
  • K212323 — Instinct Plus Endoscopic Clipping Device (August 25, 2021)
  • K201322 — Entuit Nasal Jejunal Feeding Tube (June 17, 2020)
  • 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)

Other clearances for product code FDI

  • K251692 — Advanced Tissue Resection Device (February 21, 2026)
  • K221713 — Polypectomy Snare (March 3, 2023)
  • K220846 — CORE-SNARE (November 21, 2022)
  • K220089 — Disposable Polyp Snare (September 22, 2022)
  • K220790 — Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare (June 27, 2022)
  • K213222 — Disposable Polypectomy Snare (June 6, 2022)
  • K212860 — SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB- (October 7, 2021)
  • K202478 — Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snare (October 8, 2020)
  • K200745 — Lariat, Hot/Cold Snare (April 21, 2020)
  • K190512 — SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (November 22, 2019)