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Panels › Gastroenterology, Urology › Product code FAJ · Class 2

Cystoscope And Accessories, Flexible/Rigid

Regulation 876.1500

5510(k)s in 12 months (92 all time)
0recalls in 12 months (22 all time)
21recalls that name a 510(k)
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Top companies in FAJ

DateFirm and productCodeLinked 510(k)
Jan 9, 2024Shirakawa Olympus Co., Ltd.
Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
Open, Classified
FAJK221683
Jan 9, 2024Shirakawa Olympus Co., Ltd.
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
Open, Classified
FAJK221683
Jan 9, 2024Shirakawa Olympus Co., Ltd.
Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
Open, Classified
FAJK221683
Jan 9, 2024Shirakawa Olympus Co., Ltd.
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
Open, Classified
FAJK221683
Jan 9, 2024Shirakawa Olympus Co., Ltd.
Model No. CYF-5R, Cystonephrofiberscope
Open, Classified
FAJK221690
Jan 9, 2024Shirakawa Olympus Co., Ltd.
Model No. CYF-5, Cystonephrofiberscope
Open, Classified
FAJK221690
Nov 17, 2023Aizu Olympus Co., Ltd.
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
Open, Classified
FAJK221683
K221690
May 3, 2022Karl Storz Endoscopy
STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video C
Open, Classified
FAJK202957
Apr 20, 2022Olympus Corporation of the Americas
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Open, Classified
FAJK993041
Apr 1, 2022Karl Storz Endoscopy
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
Open, Classified
FAJK082046
Oct 9, 2019Medivators, Inc.
Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and s
Terminated
FAJK093665
Oct 9, 2019Medivators, Inc.
Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Cont
Terminated
FAJK093665
Oct 9, 2019Medivators, Inc.
Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile
Terminated
FAJK093665
Oct 9, 2019Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes Wit
Terminated
FAJK093665
Oct 9, 2019Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Steri
Terminated
FAJK093665
Oct 9, 2019Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile
Terminated
FAJK093665
Oct 9, 2019Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - P
Terminated
FAJK093665
Jul 13, 2017Pentax of America Inc
Video Cystoscope models ECY-1570 and ECY-1570K
Terminated
FAJNone listed
Jun 28, 2016Pentax Medical Company
Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the
Terminated
FAJK914008
Apr 14, 2016Customed, Inc
Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FAJK902274
Sep 3, 2015Customed, Inc
CYSTO TUR PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
FAJK902274
Sep 3, 2015Customed, Inc
CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
FAJK902274

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