510(k) K233264

Anthogyr INTEGRAL Guided Surgery Cassettes by Anthogyr — Product Code KCT

K233264 is an FDA 510(k) premarket notification submitted by Anthogyr for the device "Anthogyr INTEGRAL Guided Surgery Cassettes". The FDA issued a decision of Substantially Equivalent on December 22, 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
December 22, 2023
Date Received
September 29, 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