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510(k) K940283

KARL STORZ ENDOVISION UROCAM/HYSTEROCAM by Medical Concepts, Inc. — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1994
Date Received
January 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Other clearances by Medical Concepts, Inc.

  • K110659 — MEDICAL CONCEPTS INTERBODY FUSION SYSTEM (September 13, 2011)
  • K883943 — CCM-1 VIDEO CAMERA SYSTEM (September 28, 1988)
  • K883944 — MEC-1 VIDEO COMBO SYSTEM (September 28, 1988)
  • K802564 — MEDICAL MAGNETIC TAPE RECORDER (November 12, 1980)

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