510(k) K883884

PROSTATIC CORE-CUT NEEDLE by Euro-Med Intl. — Product Code KNW

K883884 is an FDA 510(k) premarket notification submitted by Euro-Med Intl. for the device "PROSTATIC CORE-CUT NEEDLE". The FDA issued a decision of Substantially Equivalent on December 5, 1988. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Euro-Med Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1988
Date Received
September 13, 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