510(k) K880098

VAN-TEC AUTO BIOPSY NEEDLE by Van-Tec, Inc. — Product Code KNW

K880098 is an FDA 510(k) premarket notification submitted by Van-Tec, Inc. for the device "VAN-TEC AUTO BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on March 2, 1988. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Van-Tec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1988
Date Received
January 12, 1988
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