FDA.reportPublic FDA data

510(k) K190099

Device
Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
Applicant
Corinth MedTech, Inc.
510(k) number
K190099
Product code
FJL  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-15
Date received
2019-01-22
Regulation
876.1500
Classification name
Resectoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sandeep Saboo
Address
1601 S. De Anza Blvd., Suite 200 Cupertino CA US 95014 95014

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FJL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232486KARL STORZ Monopolar Resectoscopes with HF CableKarl Storz SE & CO. KG2024-05-07
K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.2023-03-17
K230205Veloxion SystemCorinth Medtech, Inc.2023-02-24
K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc.2019-06-13
K162979Veloxion SystemCorinth Medtech, Inc.2017-03-24
K102663AED RESECTOSCOPENational Advanced Endoscopy Devices, Inc.2010-12-30
K062720S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODESRichard Wolf Medical Instruments Corp.2007-03-22
K042523RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIESRichard Wolf Medical Instruments Corp.2005-03-18
K041610MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207Richard Wolf Medical Instruments Corp.2004-08-19
K001270GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODEGyrus Medical , Ltd.2000-04-28
K971881COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORSComeg Endoscopy1997-08-12
K964892FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)Gynecare Innovation Center1997-02-04
K962506[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]Gynecare Innovation Center1996-09-16
K960757KARL STORZ URETER RESECTOSCOPEKARL STORZ Endoscopy-America, Inc.1996-05-01
K954050RESECTOSCOPESKARL STORZ Endoscopy-America, Inc.1995-11-22