SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM— 510(k) K131078
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K131078 for SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM, Substantially Equivalent on 2013-07-05. 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 K131078
K-number listed on FDA's recall record- Z-1180-2016 — Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.
- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131078.
Data sourced from openFDA. This site is unofficial and independent of the FDA.