Panels › Gastroenterology, Urology

Gastroenterology, Urology devices

435 product codes reviewed by the Gastroenterology, Urology panel. 11,354 510(k) clearances and 4,428 recalls in the FDA data, 79% of those recalls name a 510(k).

240510(k)s in 12 months

323recalls in 12 months

3,512recalls that name a 510(k)

Active product codes, Class I

Code	Device	Class	Recalls, 12 mo
FCL	Forceps, Biopsy, Non-Electric	1	3
FON	Bag, Drainage, With Adhesive, Ostomy	1	3
EXG	Bag, Urine Collecting, Ureterostomy	1	1
FFT	Electrode, Ph, Stomach	1	1
FKG	Tray, Start/Stop (Including Contents), Dialysis	1	1

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