FCF · Class II · 21 CFR 876.1075

FDA Product Code FCF: Instrument, Biopsy, Mechanical, Gastrointestinal

Leading manufacturers include Vidacare Corporation, Zimmar Consulting , Ltd. and Endovations.

6
Total
6
Cleared
134d
Avg days
1984
Since

FDA 510(k) Cleared Instrument, Biopsy, Mechanical, Gastrointestinal Devices (Product Code FCF)

6 devices
1–6 of 6
Cleared May 21, 2007
POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
K070759
Vidacare Corporation
Gastroenterology & Urology · 62d
Cleared Nov 30, 2006
POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM
K062833
Vidacare Corporation
Gastroenterology & Urology · 70d
Cleared Dec 07, 1999
BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
K984168
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 382d
Cleared Jan 10, 1992
AMCATH DISPOSABLE BIOPSY FORCEPS
K915142
Intl. Medical, Inc.
Gastroenterology & Urology · 57d
Cleared Aug 07, 1991
OVAL CUP BIOPSY FORCEP
K911155
Endovations
Gastroenterology & Urology · 145d
Cleared Dec 05, 1984
PHARMA-PLAST RECTAL TIP
K843477
Zimmar Consulting , Ltd.
Gastroenterology & Urology · 90d

About Product Code FCF - Regulatory Context