510(k) K231291

Perforated Baskets by Richard Wolf Medical Instruments Corporation — Product Code KCT

K231291 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corporation for the device "Perforated Baskets". The FDA issued a decision of Substantially Equivalent on June 3, 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. Richard Wolf Medical Instruments Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2024
Date Received
May 4, 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