510(k) K951421

GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES by Global Medical Products, Ltd. — Product Code FCG

K951421 is an FDA 510(k) premarket notification submitted by Global Medical Products, Ltd. for the device "GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES". The FDA issued a decision of Substantially Equivalent on November 16, 1995. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Global Medical Products, Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1995
Date Received
March 28, 1995
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