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510(k) K091600

Device
DIRECTVISION GUIDE SYSTEM
Applicant
PERCUVISION LLC
510(k) number
K091600
Product code
FGC  
Decision
Substantially Equivalent (SESE)
Decision date
2009-08-25
Date received
2009-06-03
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
ERROL O SINGH, M.D.
Address
765 N. Hamilton Rd. Suite 260a Gahanna OH US 43230 43230

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
K945907KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURESKARL STORZ Endoscopy-America, Inc.1995-05-12
K800913GYNECOLOGICAL CYSTO/URETHROSCOPEKli1980-05-14

Legacy Summary#

summary

FDA Review#

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