SteriBest® Sterilization Tray System— 510(k) K253187

Name: FDA 510(k) clearance K253187
Creator: U.S. Food and Drug Administration
Published: 2026-06-18

Substantially Equivalent

Mastel Surgical

FDA 510(k) clearance K253187 for SteriBest® Sterilization Tray System, Substantially Equivalent on 2026-06-18. Applicant: Mastel Surgical. Device class: 2.

Clearance details

Applicant: Mastel Surgical
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2025-09-26
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rapid City, SD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCT

view all

K253988 — LiteSet Trays2026-09-08
K261935 — Surgical and Prosthetic Trays2026-09-04
K252854 — SteriTite Container System with MediTray Products2026-06-03
K260726 — Straumann® ProClean Cassette (041.800; 041.801)2026-06-03
K253791 — PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid2026-02-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.