FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
K Number: K190104
·
Decision Mar 22, 2019
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
63
Applicant Total
7
Review Days
59
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Basic Information
- Device Name
- SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
- K Number
- K190104
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.6885
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Steris Corporations
- Date Received
- January 22, 2019
- Decision Date
- March 22, 2019
- Product Code
- MED
- 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 |
|---|---|---|---|
| MED | Sterilant, Medical Devices | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MED), ordered by most recent decision date.
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Steris Corporations
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| K182931 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag | Nov 20, 2018 | Substantially Equivalent |
| K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing System | Apr 4, 2018 | Substantially Equivalent |
| K172748 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack | Feb 9, 2018 | Substantially Equivalent |