510(k) K983218

N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE by Avid N.I.T., Inc. — Product Code FCG

K983218 is an FDA 510(k) premarket notification submitted by Avid N.I.T., Inc. for the device "N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on November 6, 1998. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Avid N.I.T., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1998
Date Received
September 14, 1998
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