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Bulb, Inflation, For Endoscope

FDA product code FCY · 3 cleared devices

Class 1 Gastroenterology, Urology
Regulation
21 CFR 876.1500
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1990-06-11 – 2010-02-22

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.

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