510(k) K223612

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) by Ranfac Corporation — Product Code KNW

K223612 is an FDA 510(k) premarket notification submitted by Ranfac Corporation for the device "Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)". The FDA issued a decision of Substantially Equivalent on Feb 21, 2023. 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
Feb 21, 2023
Date Received
Dec 5, 2022
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)