510(k) K914732

CORE MEDICAL BIOPSY NEEDLE by Core Medical, Inc. — Product Code FCG

K914732 is an FDA 510(k) premarket notification submitted by Core Medical, Inc. for the device "CORE MEDICAL BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on January 7, 1992. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Core Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1992
Date Received
October 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type