FDA 510(k) Applications Submitted by Olympus Winter & Ibe Gmbh

FDA 510(k) Number Submission Date Device Name Applicant
K223183 10/12/2022 Light-Guide Cables Olympus Winter & Ibe GmbH
K141225 05/12/2014 ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD OLYMPUS WINTER & IBE GMBH
K142525 09/08/2014 PK Lap Loop Olympus Winter & Ibe GmbH
K231777 06/16/2023 Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) Olympus Winter & Ibe GmbH
K180200 01/24/2018 ESG-300, APU-300, Pressure Reducer, MAPC Probes Olympus Winter & Ibe GmbH
K190744 03/22/2019 ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) Olympus Winter & Ibe GmbH
K171692 06/07/2017 Instrument basket, for EndoEYE Olympus Winter & Ibe GmbH
K171965 06/30/2017 Resection Electrodes with HF cable Olympus Winter & Ibe GmbH
K172535 08/22/2017 Bipolar applicator CELON ProCurve V Olympus Winter & Ibe GmbH
K182587 09/20/2018 Device Electrosurgical Generator ESG-150 Olympus Winter & Ibe GmbH
K203277 11/06/2020 Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps Olympus Winter & Ibe GmbH
K203492 11/19/2020 Instrument tray, for semi-rigid ureteroscope Olympus Winter & Ibe GmbH
K160053 01/11/2016 Monopolar single-use HF cable Olympus Winter & Ibe GmbH
K160249 02/01/2016 ULTRA Telescopes Olympus Winter & Ibe GmbH
K210651 03/04/2021 Resection Electrodes with HF cable Olympus Winter & Ibe GmbH
K160639 03/07/2016 Electrosurgical Generator ESG-200 OLYMPUS WINTER & IBE GMBH
K161600 06/09/2016 Resection Electrodes OLYMPUS WINTER & IBE GMBH
K213207 09/29/2021 Sheath, Stopcock Accessory Olympus Winter & Ibe GmbH
K203682 12/17/2020 Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action Olympus Winter & Ibe GmbH
K150633 03/11/2015 ULTRA Telescopes OLYMPUS WINTER & IBE GMBH
K151191 05/04/2015 OES ELITE Telescopes, Protective Tube OLYMPUS WINTER & IBE GMBH
K152092 07/28/2015 Resection Electrodes Olympus Winter & Ibe GmbH
K020507 02/15/2002 OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 OLYMPUS WINTER & IBE GMBH
K050502 02/28/2005 SINGLE USE BALLOON DILATOR MAXPASSTM OLYMPUS WINTER & IBE GMBH
K992141 06/24/1999 OLYMPUS WORKING ELEMENT FOR PROBES OLYMPUS WINTER & IBE GMBH
K983811 10/28/1998 UNIPOLAR OPTICAL BIOPSY FORCEPS OLYMPUS WINTER & IBE GMBH
K221522 05/26/2022 HF-cables (resusable) Olympus Winter & Ibe Gmbh
K120418 02/10/2012 ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES OLYMPUS WINTER & IBE GMBH
K140624 03/11/2014 HICURA HAND INSTRUMENTS OLYMPUS WINTER & IBE GMBH
K130819 03/25/2013 CLL- V1 LIGHT SOURCE OLYMPUS WINTER & IBE GMBH
K133311 10/28/2013 ENDOLED OLYMPUS WINTER & IBE GMBH
K102781 09/27/2010 RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS OLYMPUS WINTER & IBE GMBH
K103032 10/12/2010 ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ OLYMPUS WINTER & IBE GMBH
K100275 02/01/2010 WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS OLYMPUS WINTER & IBE GMBH
K110748 03/17/2011 OLYMPUS INSTRUMENT TRAY OLYMPUS WINTER & IBE GMBH
K090980 04/07/2009 HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L OLYMPUS WINTER & IBE GMBH
K200369 02/14/2020 OES Elite Ureteroscopes and Accessories Olympus Winter & Ibe GmbH
K973232 08/28/1997 OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT OLYMPUS WINTER & IBE GMBH
K033222 10/03/2003 OLYMPUS STERILIZATION TRAYS OLYMPUS WINTER & IBE GMBH
K033651 11/20/2003 OLYMPUS VIDEO URETEROSCOPE, NTSC OLYMPUS WINTER & IBE GMBH


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