Search Results
Found 2 results
510(k) Data Aggregation
K Number
K122978Device Name
SANICLAVE 102, MODEL RS-SC-102
Manufacturer
Date Cleared
2013-05-23
(239 days)
Product Code
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Revolutionary Science Saniclave 102 is designed to be used in medical and dental clinics, hospitals and other facilities where reusable sterile equipment is used. It is intended to sterilize unwrapped heat and moisture stable solid instruments, mated surfaces, knurled and hinged devices (excluding lumened devices and dental hand pieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes. Unwrapped instruments that were sterilized should be used immediately after sterilization is completed (immediate use sterilization). The chamber must be manually drained and wiped dry after each cycle.
Device Description
The Saniclave 102 by Revolutionary Science (model number RS-SC-102) is a 120 volt autoclave. The Saniclave works like most other table top steam sterilizers by boiling water in a pressurized vessel (or chamber). As the water boils, the chamber pressurizes and the steam sterilizes the instruments placed inside. The Saniclave technology is based on the scientific concept that prolonged saturated pressurized steam at or over a temperature of 121 degrees Celsius kills bacteria.
Ask a Question
Ask a specific question about this device
K Number
K112811Device Name
SANICLAVE 200
Manufacturer
Date Cleared
2012-01-11
(106 days)
Product Code
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Revolutionary Science Saniclave 200 is designed to be used in medical and dental clinics, hospitals and other facilities where reusable sterile equipment is used. It is intended to sterilize wrapped and unwrapped heat and moisture stable solid instruments, mated surfaces, knurled and hinged devices (excluding lumened devices and dental hand pieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes.
Device Description
The Saniclave 200 by Revolutionary Science (model number RS-SC-200) is a 120 volt front loading autoclave. The Saniclave works like most other table top steam sterilizers by boiling water in a pressurized vessel (or chamber). As the water boils, the chamber pressurizes and the steam sterilizes the instruments placed inside. The single heating element (permantently affixed to the bottom inside the chamber with bulkhead fittings) generates all heat for the autoclave, including preheat, sterilization and dry modes. It is immersed in the water of the chamber. When the cycle is initiated the heater turns on and boils the water.
Ask a Question
Ask a specific question about this device
Page 1 of 1