Identifiers
- 510(k) Number
- K190027 FDA 510(k)
- FDA Product Code
- ORC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5070 FDA 510(k)
- Regulation Number
- 878.5070 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SteriStay Mobile Instrument Table is a Portable Air Filter Apparatus designed to maintain a sterile environment by generating a directed, laminar airflow over surgical instruments and supplies. Its primary function is to reduce airborne contamination through HEPA filtration, ensuring a controlled, non-turbulent airflow to protect sterile fields during surgical procedures. Classified as a Class II device, it adheres to regulatory standards for cleanroom-like conditions in operating environments.
Supplied as a single-use device, the SteriStay features a 60 cm wide work surface with adjustable height, incorporating a high-efficiency particulate air (HEPA) filter rated H14 (99.995% MPPS) to capture airborne particles. It is intended for use in operating rooms and is authorized under FDA 510(k) clearance (K190027) and EU MDR compliance. Storage and handling must follow manufacturer guidelines to preserve sterility and functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Toul Meditech - Steristay, Toul Meditech, PDF SteriStay_Produktinfo_120404, Toul Meditech AB - RevMed
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190027 | Class II | Active |
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Manufacturer
- Manufacturer
- Toul Meditech AB
Sources (2)
- FDA 510(k) K190027 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026