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510(k) K091600

DIRECTVISION GUIDE SYSTEM by Percuvision, LLC — Product Code FGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2009
Date Received
June 3, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urethroscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Percuvision, LLC

  • K110214 — DIRECTVISION CATHETER, UNCOATED (May 27, 2011)
  • K090262 — PERCUCATH URINARY CATHETER (May 28, 2009)

Other clearances for product code FGC

  • K945907 — KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC E (May 12, 1995)
  • K800913 — GYNECOLOGICAL CYSTO/URETHROSCOPE (May 14, 1980)