FCI — Punch, Biopsy Class II

FDA Device Classification

Classification Details

Product Code
FCI
Device Class
Class II
Regulation Number
876.1075
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K895885national-standardAUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTINGFebruary 9, 1990
K894627integrated display technologyBT-338N ELECTRONIC CLINICAL THERMOMETEROctober 23, 1989
K875119advanced diagnostic medical systemsBIOPSY ATTACH. FOR ADMS ULTRASOUND PROBEMarch 2, 1988
K853104august c. stiefel research instituteDISPOSABLE, STERILE BIOPSY PUNCHOctober 4, 1985
K831317diasonicsBIOPSY ATTACHMENTMay 18, 1983