FDA.reportPublic FDA data

510(k) K223183

Device
Light-Guide Cables
Applicant
Olympus Winter & Ibe GmbH
510(k) number
K223183
Product code
HBI
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-13
Date received
2022-10-12
Regulation
878.4580
Classification name
Illuminator, Fiberoptic, Surgical Field
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ali Sayad
Address
Kuehnstr, 61 Hamburg DE 22045 22045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HBI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K163185OptiLux LED IlluminatorIsolux, LLC2016-11-21
K141781KOGENT SPETZLER LIGHTED SUCTION TUBESKatalyst Surgical, LLC2015-04-09
K111342LIGHT GUIDE CABLESchott North America2011-11-25
K0529791125 XSB XENON FIBER-OPTIC LIGHT SOURCEIsolux, LLC2005-10-31
K021931ENDOSCOPIC FIBEROPTIC CABLEGulf Medical Fiberoptics2002-09-06
K991208ENDOSCOPIC FIBEROPTIC CABLEIsolux America1999-06-23
K983277LIGHTSOURCE OR ILLUMINATOR MODEL I-100Cuda Products Co.1998-12-16
K933593LUMINOUS 150 FIBEROPTIC ILLUMINATORProgressive Dynamics, Inc.1993-10-28
K922837S1500 XENON LIGHT SOURCEEndomedix1992-11-03
K922462NEXTEC FIBEROPTIC CABLESNextec Corp.1992-09-21
K921866LUMINOUS 250 FIBEROPTIC ILLUMINATORProgressive Dynamics, Inc.1992-07-08
K920167NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KELNextec Corp.1992-03-23
K904616STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATORStorz Instrument Co.1991-04-19
K904609XENON LIGHT SOURCEMedical Dynamics, Inc.1990-12-18
K904681VLS 5300 300W XENON LIGHT SOURCEVistek Corp.1990-12-18