510(k) K981796

LIGHT SABER CORE TISSUE NEEDLE by Minrad, Inc. — Product Code KNW

K981796 is an FDA 510(k) premarket notification submitted by Minrad, Inc. for the device "LIGHT SABER CORE TISSUE NEEDLE". The FDA issued a decision of Substantially Equivalent on August 5, 1998. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Minrad, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1998
Date Received
May 21, 1998
Clearance Type
Traditional
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