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510(k) K945907

Device
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
510(k) number
K945907
Product code
FGC  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-12
Date received
1994-12-02
Regulation
876.1500
Classification name
Urethroscope
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
BETTY M JOHNSON
Address
600 Corporate Pt.e Culver City CA US 90230 90230

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FGC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091600DIRECTVISION GUIDE SYSTEMPercuvision, LLC2009-08-25
K800913GYNECOLOGICAL CYSTO/URETHROSCOPEKli1980-05-14

Legacy Summary#

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FDA Review#

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