ONE TRAY SEALED STERILIZATION CONTAINER— 510(k) K052567

Name: FDA 510(k) clearance K052567
Creator: U.S. Food and Drug Administration
Published: 2006-03-13

Substantially Equivalent

Sterile Containment Technology, LLC

FDA 510(k) clearance K052567 for ONE TRAY SEALED STERILIZATION CONTAINER, Substantially Equivalent on 2006-03-13. Applicant: Sterile Containment Technology, LLC. Device class: 2.

Clearance details

Applicant: Sterile Containment Technology, LLC
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2005-09-19
Decision date: 2006-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Point Richmond, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K052567

K-number listed on FDA's recall record

Z-0153-2016 — OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devicesClass II·Terminated·Innovative Sterlization Technologies LLC·20140203

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052567.

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