510(k) K230680

Anthogyr Surgical Cassettes by Anthogyr — Product Code KCT

K230680 is an FDA 510(k) premarket notification submitted by Anthogyr for the device "Anthogyr Surgical Cassettes". The FDA issued a decision of Substantially Equivalent on July 11, 2023. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Anthogyr has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2023
Date Received
March 13, 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