FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
STATIM 2000 G4 CASSETTE
K Number: K112872
·
Decision Jul 10, 2012
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
11
Review Days
284
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STATIM 2000 G4 CASSETTE
- K Number
- K112872
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scican , Ltd.
- Date Received
- September 30, 2011
- Decision Date
- July 10, 2012
- Product Code
- FLE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FLE), ordered by most recent decision date.
Enbio PRO
FDA 510(k)
FDA Class 2
·General Hospital
Getinge GSS67N Series Steam Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
Cassette Autoclave (ACA5)
FDA 510(k)
FDA Class 2
·General Hospital
Steam Sterilizer (2545D)
FDA 510(k)
FDA Class 2
·General Hospital
FRONT-LINE Field Sterilizer (FL135)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Scican , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K214057 | STATIM 6000B Vacuum Autoclave | Mar 31, 2022 | Substantially Equivalent |
| K210326 | Bravo G4 Chamber Autoclave | Jul 1, 2021 | Substantially Equivalent |
| K192910 | STATClave G4 Chamber Autoclave | Jun 19, 2020 | Substantially Equivalent |
| K190062 | STATCLAVE G4 Chamber Autoclave | Jul 26, 2019 | Substantially Equivalent |
| K172292 | SALUS - Hygiene Instrument Reprocessing Container | Nov 24, 2017 | Substantially Equivalent |
| K090937 | E-STATIS 40 SYSTEM | Jul 24, 2009 | Substantially Equivalent |
| K090265 | BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V | May 15, 2009 | Substantially Equivalent |
| K073319 | STATMATIC 31 HANDPIECE MAINTENANCE UNIT | Feb 4, 2008 | Substantially Equivalent |
| K072466 | STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 | Dec 19, 2007 | Substantially Equivalent |
| K071891 | STATIS DENTAL HANDPIECES | Sep 13, 2007 | Substantially Equivalent |