FDA.reportPublic FDA data

510(k) K022490

Device
KSEA MEDI PACK
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
510(k) number
K022490
Product code
GCT  
Decision
Substantially Equivalent (SESE)
Decision date
2003-09-29
Date received
2002-07-29
Regulation
876.1500
Classification name
Light Source, Endoscope, Xenon Arc
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAMES A LEE
Address
600 Corporate Pt.e 5th Floor Culver City CA US 90230 90230

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GCT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093125ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbH2010-01-27
K082925XENON-100 SCB LIGHT SOURCE, MODEL 20132620KARL STORZ Endoscopy-America, Inc.2008-12-18
K070376CONMED LINVATEC 300W XENON LIGHT SOURCEConmed Linvatec2007-08-20
K040949VIADUCT MINISCOPE AND ACCESSORIESAcueity, Inc.2004-05-07
K031994LINVATEC 300W XENON LIGHT SOURCELinvatec Corp.2003-08-21
K023468ENDOSCOPIC LIGHT SOURCE XL180/L3World of Medicine Lemke GmbH2003-01-14
K021717ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5World of Medicine Lemke GmbH2002-08-20
K020889ENDOSCOPIC LIGHT SOURCE XL202/L3World of Medicine Lemke GmbH2002-06-05
K013880DAYLITE XENON LIGHT SOURCESDesigns For Vision, Inc.2001-12-07
K992540XENON LIGHT SOURCE PES 1Laser Optik Systeme GmbH & Co. KG1999-09-14
K992050LUMENON XENON LIGHT SOURCEWalter Lorenz Surgical, Inc.1999-09-14
K983628XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011Richard Wolf Medical Instruments Corp.1998-12-11
K982962XENON LIGHT SOURCE, MODELS LS6180, LS6035Contec Medical Vision, Ltd.1998-09-23
K981804XENON LIGHT SOURCE MODEL LS6000Contec Medical Vision, Ltd.1998-07-24
K980281WELCH ALLYN XENON 300 LIGHT SOURCEWelch Allyn, Inc.1998-02-27

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases