510(k) K022169

CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES by Parallax Medical, Inc. — Product Code KNW

K022169 is an FDA 510(k) premarket notification submitted by Parallax Medical, Inc. for the device "CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES". The FDA issued a decision of Substantially Equivalent on July 25, 2002. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Parallax Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2002
Date Received
July 3, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type