510(k) K243207

BD Vacutainer® Eclipse™ Blood Collection Needle by Becton, Dickinson and Company — Product Code JKA

K243207 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Vacutainer® Eclipse™ Blood Collection Needle". The FDA issued a decision of Substantially Equivalent on July 3, 2025. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
October 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type