FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EOGas 4 Ethylene Oxide Gas Sterilizer
K Number: K192978
·
Decision Nov 12, 2020
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
25
Applicant Total
19
Review Days
385
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Basic Information
- Device Name
- EOGas 4 Ethylene Oxide Gas Sterilizer
- K Number
- K192978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Andersen Sterilizers, Inc.
- Date Received
- October 24, 2019
- Decision Date
- November 12, 2020
- Product Code
- FLF
- 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 |
|---|---|---|---|
| FLF | Sterilizer, Ethylene-Oxide Gas | FDA class 2 | General Hospital |
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Other Clearances by Andersen Sterilizers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213296 | Anprolene SteriTest RRBI | Apr 12, 2022 | Substantially Equivalent |
| K202879 | EOGas 4 Endo-SteriTest RRBI | Mar 3, 2021 | Substantially Equivalent |
| K200334 | AN1036 Dosimeter | Nov 12, 2020 | Substantially Equivalent |
| K200335 | Sterisheet Sterilization Wrap | Nov 12, 2020 | Substantially Equivalent |
| K192980 | EOGas 4 Endo-SteriTest | Nov 12, 2020 | Substantially Equivalent |
| K200336 | Tyvek Sterilization Pouches with Chevron Seal | Nov 12, 2020 | Substantially Equivalent |
| K170437 | Sterisheet Sterilization Wrap | Nov 1, 2017 | Substantially Equivalent |
| K170439 | AN87 Dosimeter | Nov 1, 2017 | Substantially Equivalent |
| K170432 | Anprolene AN75 Ethylene Oxide Gas Sterilizer | Oct 31, 2017 | Substantially Equivalent |
| K170427 | Anprolene SteriTest | Oct 31, 2017 | Substantially Equivalent |