510(k) K233578

BAHADIR STERILIZATION CONTAINERS by Bahadir USA, LLC — Product Code KCT

K233578 is an FDA 510(k) premarket notification submitted by Bahadir USA, LLC for the device "BAHADIR STERILIZATION CONTAINERS". The FDA issued a decision of Substantially Equivalent on March 22, 2024. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Bahadir USA, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2024
Date Received
November 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type