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Wilson-Cook Medical Inc.

FDA Regulatory Profile

Summary

Total Recalls
22
510(k) Clearances
125
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1362-2026Class IITeslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002December 18, 2025
Z-1298-2026Class IIProduct Name: Nasal Jejunal Feeding Tube REF: NJFT-10December 15, 2025
Z-0582-2025Class IICook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.October 31, 2024
Z-0036-2025Class IICook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 HemospraAugust 29, 2024
Z-0458-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate stricturesNovember 3, 2023
Z-0460-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures ofNovember 3, 2023
Z-0457-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures oNovember 3, 2023
Z-0461-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures November 3, 2023
Z-0463-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures November 3, 2023
Z-0459-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures ofNovember 3, 2023
Z-0462-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures ofNovember 3, 2023
Z-2252-2023Class IIFusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy ExtractionJune 22, 2023
Z-2253-2023Class IIFusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction June 22, 2023
Z-1978-2023Class IIHemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G2May 22, 2023
Z-1979-2023Class IIHemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF May 22, 2023
Z-1746-2020Class IIHEMO-10 Hemospray Endoscopic HemostatFebruary 4, 2020
Z-1745-2020Class IIHEMO-7 Hemospray Endoscopic HemostatFebruary 4, 2020
Z-2541-2019Class IIHemospray Endoscopic HemostatJuly 24, 2019
Z-2089-2019Class IIAcuject Variable Injection NeedleJune 14, 2019
Z-1132-2019Class IIAcusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic poJanuary 4, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K251104SureTome™ SW Sphincterotome with DomeTipSeptember 29, 2025
K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordJanuary 17, 2025
K213356Entuit PEG, Entuit PEGJJanuary 20, 2022
K212323Instinct Plus Endoscopic Clipping DeviceAugust 25, 2021
K201322Entuit Nasal Jejunal Feeding TubeJune 17, 2020
K200972Hemospray Endoscopic HemostatJune 10, 2020
K200247Fusion Quattro Extraction BalloonFebruary 27, 2020
K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordJanuary 30, 2020
K193344Tri-Ex Extraction Balloon with Multiple SizingDecember 13, 2019
K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesNovember 14, 2019
K191048AcuSnare Polypectomy Snare - DuckbillJuly 18, 2019
K183336Entuit PEG, Entuit PEGJMay 29, 2019
K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushFebruary 8, 2019
K182319Glo-Tip Spray CatheterFebruary 1, 2019
K182895Wilson-Cook Achalasia BalloonJanuary 25, 2019
K182381Wilson-Cook Mini BasketOctober 30, 2018
K173673AcuSnare Polypectomy SnareAugust 24, 2018
K173659Howell D.A.S.H Extraction Balloon with Multiple SizingJuly 6, 2018
DEN170015Hemospray Endoscopic HemostatMay 7, 2018
K171969Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire March 28, 2018