Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter

FDA 510(k) Premarket Notification · Submission K171989 · Applicant: Wilson-Cook Medical, Inc.

Public Record 510(k) Submission Decision Date: 2018-03-20 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K171989.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K171989

Applicant / Sponsor

Wilson-Cook Medical, Inc.

Device Name

Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter

Product Code

ODD

Decision Date

2018-03-20

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Traditional

Third Party Flag

Date Received

2017-07-03

Related Establishments / Registrations

Boston Scientific Corporation Registration: 1000121056 View Registration
COOK INCORPORATED Registration: 1000393132 View Registration
Wilson-Cook Medical Inc. Registration: 1037905 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
Conmed Corporation Registration: 1223925 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
CONMED CORPORATION Registration: 1320894 View Registration
UNITED STATES ENDOSCOPY GROUP, INC. Registration: 1528319 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 3005099803 View Registration
Consolidated Medical Equipment Company Registration: 3007305485 View Registration
Boston Scientific Corporation Registration: 3007695959 View Registration
Aomori Olympus Co., Ltd. Hirosaki Site Registration: 3014769442 View Registration
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
OLYMPUS MEDICAL SYSTEMS CORP. Registration: 8010047 View Registration
AOMORI OLYMPUS CO., LTD. Kuroishi Site Registration: 9614641 View Registration
Venusa de Mexico S. de R.L de C.V Registration: 9680001 View Registration
Boston Scientific Limited Registration: 9681260 View Registration

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