510(k) K924271

CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES by Core Medical, Inc. — Product Code FCG

K924271 is an FDA 510(k) premarket notification submitted by Core Medical, Inc. for the device "CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES". The FDA issued a decision of Substantially Equivalent on November 23, 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
November 23, 1992
Date Received
August 24, 1992
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