Company ยท CA
Scican , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2022. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FLE | Sterilizer, Steam | 15 |
| EFB | Handpiece, Air-Powered, Dental | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 1 |
| EBW | Controller, Foot, Handpiece And Cord | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 |
| ELW | Material, Impression | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 2022 | K214057 | STATIM 6000B Vacuum Autoclave Scican , Ltd., CA | FLE |
| Jul 1, 2021 | K210326 | Bravo G4 Chamber Autoclave Scican , Ltd., CA | FLE |
| Jun 19, 2020 | K192910 | STATClave G4 Chamber Autoclave Scican , Ltd., CA | FLE |
| Jul 26, 2019 | K190062 | STATCLAVE G4 Chamber Autoclave Scican , Ltd., CA | FLE |
| Nov 24, 2017 | K172292 | SALUS - Hygiene Instrument Reprocessing Container Scican , Ltd., CA | KCT |
| Jan 31, 2014 | K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST Scican GmbH, DE | EGS |
| Jul 10, 2012 | K112872 | STATIM 2000 G4 CASSETTE Scican , Ltd., CA | FLE |
| Jul 24, 2009 | K090937 | E-STATIS 40 SYSTEM Scican , Ltd., CA | EBW |
| May 15, 2009 | K090265 | BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V Scican , Ltd., CA | FLE |
| Feb 4, 2008 | K073319 | STATMATIC 31 HANDPIECE MAINTENANCE UNIT Scican , Ltd., CA | EFB |
| Dec 19, 2007 | K072466 | STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 Scican , Ltd., CA | FLE |
| Sep 13, 2007 | K071891 | STATIS DENTAL HANDPIECES Scican , Ltd., CA | EFB |
| Oct 19, 2006 | K062418 | K-SPRAY, MODEL 085-2715 Scican, CA | EFB |
| Aug 8, 2002 | K021064 | QUANTIM 16 AUTOCLAVE Scican, CA | FLE |
| Jan 4, 1999 | K983679 | STATIM 5000 CASSETTE AUTOCLAVE Scican, CA | FLE |
| Feb 4, 1997 | K964691 | TCB TEMPORARY CROWN AND BRIDGE MATERIAL Scican, CA | EBG |
| Jan 13, 1997 | K962179 | STAT IM 5000 CASSETTE AUTOCLAVE Scican | FLE |
| Oct 2, 1996 | K944036 | STERIMASTER AUTOCLAVE Scican, CA | FLE |
| Jan 11, 1995 | K945142 | POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) Scican, CA | ELW |
| Aug 4, 1992 | K915054 | STATIM CASSETT AUTOCLAVE, MODIFICATION Scican, CA | FLE |
| May 3, 1991 | K910241 | STATIM CASSETTE AUTOCLAVE Scican, CA | FLE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2023 | Scican Ltd. STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
Model: G4 622303 Open, Classified |
FLE | K192910 |
| Aug 3, 2023 | Scican Ltd. STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
Model: G4 621103 Open, Classified |
FLE | K190062 |