510(k) K902461

MEADOX SURGIMED BIOPSY GUN AND NEEDLE by Meadox Surgimed, Inc. — Product Code KNW

K902461 is an FDA 510(k) premarket notification submitted by Meadox Surgimed, Inc. for the device "MEADOX SURGIMED BIOPSY GUN AND NEEDLE". The FDA issued a decision of Substantially Equivalent on July 16, 1990. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Meadox Surgimed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1990
Date Received
June 4, 1990
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