Product code FCY— Gastroenterology, Urology

ANEROID BLOOD PRESSURE GAUGE

Classification name: Bulb, Inflation, For Endoscope
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Total cleared: 3
First cleared: 1990-06-11
Most recent: 2010-02-22

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code FCY under 21 CFR 876.1500, via openFDA

Market context for product code FCY

FDA has cleared 3 devices under product code FCY between 1990 and 2010, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

20101 clearance
19902 clearances

Top applicants under product code FCY

Zutron Medical, LLC1 clearance
CIVCO Medical Instruments Co., Inc.1 clearance
Biomedical Dynamics, Inc.1 clearance

Recent clearances under product code FCY

K093718 — ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003Zutron Medical, LLC·2010-02-22
K904376 — ANEROID BLOOD PRESSURE GAUGEBiomedical Dynamics, Inc.·1990-12-20
K900016 — TRANS/R - FP(3)CIVCO Medical Instruments Co., Inc.·1990-06-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.