FDA.report

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

Related Records

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)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