510(k) K190177

J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, by Ranfac Corporation — Product Code KNW

K190177 is an FDA 510(k) premarket notification submitted by Ranfac Corporation for the device "J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,". The FDA issued a decision of Substantially Equivalent on Jun 12, 2019. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Ranfac Corporation has 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 12, 2019
Date Received
Feb 1, 2019
Clearance Type
Special
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
510(k)