510(k) K242762

Aesculap Aicon® Series Container System by Aesculap, Inc. — Product Code KCT

K242762 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "Aesculap Aicon® Series Container System". The FDA issued a decision of Substantially Equivalent on May 13, 2025. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2025
Date Received
September 12, 2024
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