SteriBest® Sterilization Tray System— 510(k) K253187
Substantially EquivalentMastel Surgical
FDA 510(k) clearance K253187 for SteriBest® Sterilization Tray System, Substantially Equivalent on 2026-06-18. Applicant: Mastel Surgical. Device class: 2.
Summary
Mastel Surgical's SteriBest Sterilization Tray System is filed under KCT, sterilization wrap containers, trays, cassettes, and other accessories. The record doesn't describe the trays' sizes, material, or contents.
Class II, 21 CFR 880.6850. General Hospital is both the classification panel and the review panel. It was a Traditional 510(k).
Mastel filed from Rapid City, South Dakota. The decision came 265 calendar days after FDA received it (September 26, 2025 to June 18, 2026).
Clearance details
- Applicant
- Mastel Surgical
- Product code
- Product code KCT
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rapid City, SD, US
Recent devices under product code KCT
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