SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM— 510(k) K113520
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K113520 for SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM, Substantially Equivalent on 2012-02-21. Applicant: STERIS Corporation. Device class: 2.
Clearance details
- Applicant
- STERIS Corporation
- Product code
- Code MED
- Device class
- Class 2
- Regulation
- 21 CFR 880.6885
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
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More clearances from STERIS Corporation
view allRecalls naming K113520
K-number listed on FDA's recall record- Z-0616-2014 — SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
- Z-1596-2013 — Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113520.
Data sourced from openFDA. This site is unofficial and independent of the FDA.