Medical Device Manufacturer · US , Melville , NY

Olympus Winter & Ibe GmbH - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 1997
42
Total
42
Cleared
0
Denied

FDA 510(k) cleared devices by Olympus Winter & Ibe GmbH Gastroenterology & Urology

15 devices
1-15 of 15
Cleared Jan 19, 2023
HF-cables (resusable)
K221522 · GEI
Gastroenterology & Urology · 238d
Cleared Aug 28, 2020
OES Elite Ureteroscopes and Accessories
K200369 · FGB
Gastroenterology & Urology · 196d
Cleared Sep 28, 2017
Resection Electrodes with HF cable
K171965 · FAS
Gastroenterology & Urology · 90d
Cleared Nov 24, 2015
OES ELITE Telescopes, Protective Tube
K151191 · FBP
Gastroenterology & Urology · 204d
Cleared Oct 26, 2015
Resection Electrodes
K152092 · FAS
Gastroenterology & Urology · 90d
Cleared Jul 30, 2014
ENDOLED
K133311 · NTN
Gastroenterology & Urology · 275d
Cleared Jun 19, 2013
CLL- V1 LIGHT SOURCE
K130819 · NTN
Gastroenterology & Urology · 86d
Cleared Jun 20, 2012
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
K120418 · FAS
Gastroenterology & Urology · 131d
Cleared Jan 11, 2011
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE...
K102781 · FAS
Gastroenterology & Urology · 106d
Cleared Jul 01, 2010
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON,...
K100275 · FAS
Gastroenterology & Urology · 150d
Cleared Jun 29, 2009
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
K090980 · NWB
Gastroenterology & Urology · 83d
Cleared Jul 08, 2005
SINGLE USE BALLOON DILATOR MAXPASSTM
K050502 · FGE
Gastroenterology & Urology · 130d
Cleared Jan 30, 2004
OLYMPUS VIDEO URETEROSCOPE, NTSC
K033651 · FGB
Gastroenterology & Urology · 71d
Cleared Sep 29, 1999
OLYMPUS WORKING ELEMENT FOR PROBES
K992141 · FDC
Gastroenterology & Urology · 97d
Cleared Dec 24, 1998
UNIPOLAR OPTICAL BIOPSY FORCEPS
K983811 · KGE
Gastroenterology & Urology · 57d
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