FCY — Bulb, Inflation, For Endoscope Class I

FDA Device Classification

Classification Details

Product Code: FCY
Device Class: Class I
Regulation Number: 876.1500
Submission Type
Review Panel: GU
Medical Specialty: Gastroenterology, Urology
Implant: No

Definition

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K093718	zutron medical	ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003	February 22, 2010
K904376	biomedical dynamics	ANEROID BLOOD PRESSURE GAUGE	December 20, 1990
K900016	civco medical instruments co	TRANS/R - FP(3)	June 11, 1990