VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU— 510(k) K092745

Name: FDA 510(k) clearance K092745
Creator: U.S. Food and Drug Administration
Published: 2010-11-19

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K092745 for VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU, Substantially Equivalent on 2010-11-19. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2009-09-08
Decision date: 2010-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K092745

K-number listed on FDA's recall record

Z-2325-2012 — 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.Class III·Terminated·Steris Corporation·20120802

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092745.

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