FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K971881 |
COMEG ENDOSCOPY |
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS |
08/12/1997 |
K190099 |
Corinth MedTech, Inc. |
Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch |
03/15/2019 |
K191341 |
Corinth MedTech, Inc. |
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags |
06/13/2019 |
K230205 |
Corinth MedTech, Inc. |
Veloxion System |
02/24/2023 |
K162979 |
Corinth MedTech, Inc. |
Veloxion System |
03/24/2017 |
K962506 |
GYNECARE INNOVATION CENTER |
[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] |
09/16/1996 |
K964892 |
GYNECARE INNOVATION CENTER |
FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) |
02/04/1997 |
K001270 |
GYRUS MEDICAL LTD. |
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE |
04/28/2000 |
K221893 |
KARL STORZ Endoscopy America, Inc |
KARL STORZ Bipolar Resectoscopes with HF Cable |
03/17/2023 |
K960757 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KARL STORZ URETER RESECTOSCOPE |
05/01/1996 |
K102663 |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
AED RESECTOSCOPE |
12/30/2010 |
K041610 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 |
08/19/2004 |
K042523 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES |
03/18/2005 |
K062720 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES |
03/22/2007 |