510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FCYClass I

Bulb, Inflation, For Endoscope

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FCY is the FDA product code for Bulb, Inflation, For Endoscope, a class I device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FCY
Device name
Bulb, Inflation, For Endoscope
FDA 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.
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code FCY

By decision year
3 clearances under product code FCY with a decision year between 1990 and 2010, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FCY by decision year
YearClearances
19902
20101

Applicants with the most clearances

Product code FCY
Applicants holding the most 510(k) clearances under product code FCY
ApplicantClearances
Biomedical Dynamics, Inc.1
CIVCO Medical Instruments Co., Inc.1
Zutron Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 43 companies shown, in name order