510(k) K013153 · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

AUTOTOME RX MODEL # 4515, 4516

Applicant	Boston Scientific Corp, Natick, MA, US
Decision	Substantially Equivalent, Oct 19, 2001
Received	Sep 20, 2001
Type	Special
FDA record	Open on fda.gov

Recalls that name K013153

Date	Firm and product	Code	Linked 510(k)
Jul 12, 2024	Boston Scientific Corporation Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct. Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation DREAMTOME 44-30MM/260CM Material Number: M00584050 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation DREAMTOME 44-30MM/450CM Material Number: M00584070 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation DREAMTOME 49-20MM/260CM Material Number: M00584000 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation DREAMTOME 49-20MM/450CM Material Number: M00584020 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation DREAMTOME 49-30MM/260CM Material Number: M00584010 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation DREAMTOME 49-30MM/450CM Material Number: M00584030 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation HYDRATOME RX 44-20MM/260CM Material Number: M00583040 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation HYDRATOME RX 44-20MM/450CM Material Number: M00583060 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation HYDRATOME RX 44-30MM/260CM Material Number: M00583050 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation HYDRATOME RX 44-30MM/450CM Material Number: M00583070 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation HYDRATOME RX 49-20MM/260CM Material Number: M00583000 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation HYDRATOME RX 49-30MM/260CM Material Number: M00583010 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 39-20-260-025 Material Number: M00573080 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 39-20-450-025 Material Number: M00573090 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 39-30-260-025 Material Number: M00573100 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 39-30-260-025 Material Number: M00573100 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 39-30-450-025 Material Number: M00573110 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 44-20-260-035 Material Number: M00573040 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 44-20-450-035 Material Number: M00573050 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 44-30-260-035 Material Number: M00573060 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 44-30-450-035 Material Number: M00573070 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 49-20-260-035 Material Number: M00573000 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 49-30-260-035 Material Number: M00573020 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation JAGTOME RX 49-30-450-035 Material Number: M00573030 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481 Open, Classified	KNS	None listed
Dec 22, 2021	Boston Scientific Corporation RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480 Open, Classified	KNS	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.