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510(k) K093718

ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 by Zutron Medical, LLC — Product Code FCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2010
Date Received
December 2, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bulb, Inflation, For Endoscope
Device Class
Class I
Regulation Number
876.1500
Review Panel
GU
Submission Type

An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles.

Other clearances by Zutron Medical, LLC

  • K051068 — ZUTRON COLONOSCOPE STIFFENING DEVICE (July 11, 2005)

Other clearances for product code FCY

  • K904376 — ANEROID BLOOD PRESSURE GAUGE (December 20, 1990)
  • K900016 — TRANS/R - FP(3) (June 11, 1990)