Scican , Ltd.
Medical device manufacturer in North York, Cana.
21510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K214057 | STATIM 6000B Vacuum AutoclaveFLE · Abbreviated | 03/31/2022SE |
| K210326 | Bravo G4 Chamber AutoclaveFLE · Abbreviated | 07/01/2021SE |
| K192910 | STATClave G4 Chamber AutoclaveFLE · Abbreviated | 06/19/2020SE |
| K190062 | STATCLAVE G4 Chamber AutoclaveFLE · Abbreviated | 07/26/2019SE |
| K172292 | SALUS - Hygiene Instrument Reprocessing ContainerKCT · Abbreviated | 11/24/2017SE |
| K132356 | Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40STEGS · Traditional | 01/31/2014SE |
| K112872 | Statim 2000 G4 CassetteFLE · Special | 07/10/2012SE |
| K090937 | E-Statis 40 SystemEBW · Traditional | 07/24/2009SE |
| K090265 | Bravo Autoclave, Models 17, 17V and 21VFLE · Abbreviated | 05/15/2009SE |
| K073319 | Statmatic 31 Handpiece Maintenance UnitEFB · Traditional | 02/04/2008SE |
| K072466 | Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model…FLE · Traditional | 12/19/2007SE |
| K071891 | Statis Dental HandpiecesEFB · Abbreviated | 09/13/2007SE |
| K062418 | K-Spray, Model 085-2715EFB · Traditional | 10/19/2006SE |
| K021064 | Quantim 16 AutoclaveFLE · Traditional | 08/08/2002SE |
| K983679 | Statim 5000 Cassette AutoclaveFLE · Special | 01/04/1999SE |
| K964691 | TCB Temporary Crown and Bridge MaterialEBG · Traditional | 02/04/1997SE |
| K962179 | Stat Im 5000 Cassette AutoclaveFLE · Traditional | 01/13/1997SE |
| K944036 | Sterimaster AutoclaveFLE · Traditional | 10/02/1996SE |
| K945142 | Polysil (Vinyl Polysiloxan Impression Material)ELW · Traditional | 01/11/1995SE |
| K915054 | Statim Cassett Autoclave, ModificationFLE · Traditional | 08/04/1992SE |
| K910241 | Statim Cassette AutoclaveFLE · Traditional | 05/03/1991SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2286-2023 Class II | STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health…The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health… | 06/22/2023Open, Classified |
| Z-2285-2023 Class II | STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health…The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health… | 06/22/2023Open, Classified |