510(k) K213616

BD Surgiphor Antimicrobial Irrigation System by Becton, Dickinson and Company — Product Code FQH

K213616 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Surgiphor Antimicrobial Irrigation System". The FDA issued a decision of Substantially Equivalent on March 23, 2022. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2022
Date Received
November 15, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type