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510(k) K800913

Device
GYNECOLOGICAL CYSTO/URETHROSCOPE
Applicant
KLI
510(k) number
K800913
Product code
FGC  
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-14
Date received
1980-04-21
Regulation
876.1500
Classification name
Urethroscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FGC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091600DIRECTVISION GUIDE SYSTEMPercuvision, LLC2009-08-25
K945907KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURESKARL STORZ Endoscopy-America, Inc.1995-05-12

Legacy Summary#

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FDA Review#

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