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510(k) K934315

Device
ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME
Applicant
ENDOVATIONS
510(k) number
K934315
Product code
KNS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-28
Date received
1993-09-01
Regulation
876.4300
Classification name
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RONALD D WOLFE
Address
Hill And George Ave.S P.O. Box 6386 Reading PA US 19610 19610

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KNS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260962SphincterotomeTaewoong Medical Co., Ltd.2026-05-21
K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.2025-11-26
K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation2025-11-25
K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.2025-10-17
K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation2025-10-10
K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical2025-09-29
K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.2025-08-08
K250584Rezum SystemBoston Scientific Corporation2025-06-11
K242774SpydrBlade Flex Instrument (PRD-RG1-001)Creo Medical, Ltd.2025-06-06
K241855SB Knife Jr2 (MD-47702 and MD-47702L)Sb-Kawasumi Laboratories, Inc.2025-03-26
K242192Disposable SphincterotomeBeijing Zksk Technology Co., Ltd.2025-02-06
K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc.2025-01-17
K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.2024-12-12
K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)Creo Medical, Ltd.2024-08-15
K232825Disposable SphincterotomeJiangsu Vedkang Medical Science and Technology Co., Ltd.2024-03-29

Legacy Summary#

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FDA Review#

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