510(k) K140991

RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE by Ranfac, Corp. — Product Code KNW

K140991 is an FDA 510(k) premarket notification submitted by Ranfac, Corp. for the device "RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE". The FDA issued a decision of Substantially Equivalent on September 11, 2014. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Ranfac, Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2014
Date Received
April 17, 2014
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