510(k) K262042
K262042 is an FDA 510(k) premarket notification submitted by Alliedstar Medical Equipment Co., Ltd. for the device "Sterilization Cassette (CASS-1)". The FDA issued a decision of Substantially Equivalent on Oct 14, 2026. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 14, 2026
- Date Received
- Jun 17, 2026
- 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
- 510(k)