STATClave G4 Chamber Autoclave
FDA 510(k)Class II (US FDA 510(k))
by Scican Ltd
Identifiers
- 510(k) Number
- K192910 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 (pre-vacuum) table-top steam sterilizer. It is classified as a steam sterilizer and designed to sterilize medical products using pressurized steam, ensuring effective removal of microbial contaminants from instruments and devices.
This device is intended for use in healthcare settings, including general hospitals, and operates as a reusable medical instrument. It incorporates pre-sterilization vacuum to enhance steam penetration and post-sterilization vacuum to improve drying. The STATClave G4 has received FDA 510(k) clearance under the classification of a Class II device (regulation number 880.6880) and is supplied as a reusable medical device.
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), PDF SciCan STATCLAVE G4, SCICAN STATCLAVE G4 OPERATOR'S MANUAL Pdf Download, PDF STATCLAVE G4 Chamber Autoclave - SciCan
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192910 | Class II | Active |
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Manufacturer
- Manufacturer
- Scican Ltd
- FDA Applicant
- Scican , Ltd.
Sources (1)
- FDA 510(k) K192910 24 fields · synced Sep 19, 2026