510(k) K934256

GLOBAL MEDICAL CUTTING BIOPSY NEEDLE by Global Medical Prods, Inc. — Product Code FCG

K934256 is an FDA 510(k) premarket notification submitted by Global Medical Prods, Inc. for the device "GLOBAL MEDICAL CUTTING BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on March 28, 1994. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Global Medical Prods, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1994
Date Received
August 31, 1993
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