Sterilizer, Steam
Scican Ltd.'s record for this product code
Recent MDR events
1 adverse event reports on file
Recalls
2 recall events for this product code
- Open, ClassifiedAug 3, 2023
The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
View FDA record ↗ - Open, ClassifiedAug 3, 2023
The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
View FDA record ↗
510(k) clearances
7 clearances for this product code
- K214057Mar 31, 2022
STATIM 6000B Vacuum Autoclave
- K210326Jul 1, 2021
Bravo G4 Chamber Autoclave
- K192910Jun 19, 2020
STATClave G4 Chamber Autoclave
- K190062Jul 26, 2019
STATCLAVE G4 Chamber Autoclave
- K112872Jul 10, 2012
STATIM 2000 G4 CASSETTE
- K090265May 15, 2009
BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V
- K072466Dec 19, 2007
STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101