STATCLAVE G4 Chamber Autoclave
FDA 510(k)Class II (US FDA 510(k))
by Scican Ltd
Identifiers
- 510(k) Number
- K190062 FDA 510(k)
- FDA Product Code
- FLE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6880 FDA 510(k)
- Regulation Number
- 880.6880 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The STATCLAVE G4 Chamber Autoclave is a dynamic-air-removal table-top steam sterilizer designed for sterilizing medical products using pressurized steam. Classified as a Class II device, it employs pre-vacuum and post-vacuum cycles to enhance steam penetration and drying efficiency, ensuring effective sterilization of dental and medical instruments validated for steam sterilization.
This device is intended for use in healthcare settings, including general hospitals, and is supplied as a reusable medical instrument. It operates under FDA 510(k) clearance (K190062) with an abbreviated review process, adhering to regulatory standards outlined in 21 CFR 880.6880. The STATCLAVE G4 is not MRI-safe and requires proper storage and maintenance as per manufacturer guidelines to ensure continued performance and sterility.
Frequently asked questions
What types of medical instruments can be sterilized using the STATCLAVE G4 Chamber Autoclave, and how does it ensure effective sterilization?
The STATCLAVE G4 Chamber Autoclave is designed specifically for sterilizing medical products validated for steam sterilization, particularly dental and medical instruments. It uses a pre-vacuum and post-vacuum cycle to improve steam penetration and drying efficiency, ensuring thorough sterilization. This process is critical for removing air pockets that could otherwise hinder steam contact with instruments, making it suitable for items like surgical tools, endodontic files, or other heat-resistant medical devices.
Is the STATCLAVE G4 Chamber Autoclave reusable, and if so, what maintenance or storage requirements does it have?
Yes, the STATCLAVE G4 is supplied as a reusable medical instrument, meaning it is built for repeated use in healthcare settings. To maintain performance and sterility, it requires proper storage and regular maintenance as outlined by the manufacturer. This includes cleaning, calibration, and adherence to operational guidelines to ensure continued reliability and compliance with sterilization standards.
Can the STATCLAVE G4 be used in an MRI environment, and if not, what precautions should be taken?
No, the STATCLAVE G4 is not MRI-safe, meaning it should never be placed in an MRI scanning area. If used in a facility with MRI capabilities, it must be stored and transported away from MRI zones to avoid interference with imaging equipment or potential safety hazards. Always follow facility protocols for non-MRI-safe equipment.
What regulatory pathway was followed for FDA clearance of the STATCLAVE G4, and what does this mean for healthcare providers?
The STATCLAVE G4 received FDA 510(k) clearance (K190062) through an abbreviated review process, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance was granted under 21 CFR 880.6880, which governs steam sterilizers. For healthcare providers, this indicates the device meets FDA safety and effectiveness standards for use in general hospitals and other healthcare settings.
What sizes or models of the STATCLAVE G4 are available, and how does this affect its suitability for different healthcare settings?
While the provided data does not specify exact sizes or model variations of the STATCLAVE G4, it is classified as a table-top steam sterilizer, which typically suggests compact, space-efficient designs suitable for smaller clinics, dental offices, or procedural rooms. The pre-vacuum and post-vacuum cycles ensure versatility for sterilizing a range of validated instruments. For larger facilities, compatibility with high-volume sterilization needs should be confirmed with the manufacturer.
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: STATCLAVE G4 | United States - SciCan (US), STATCLAVE | United States - SciCan (US), PDF SciCan STATCLAVE G4
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190062 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scican Ltd
- FDA Applicant
- Scican , Ltd.
Sources (1)
- FDA 510(k) K190062 24 fields · synced Sep 19, 2026