| Device Type ID | 2540 |
| Device Name | Sterilizer, Ethylene-oxide Gas |
| Regulation Description | Ethylene Oxide Gas Sterilizer. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FLF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2540 |
| Device | Sterilizer, Ethylene-oxide Gas |
| Product Code | FLF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ethylene Oxide Gas Sterilizer. |
| CFR Regulation Number | 880.6860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANDERSEN STERILIZERS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Overheating Of Device | 2 |
Temperature Problem | 2 |
Device Sensing Problem | 2 |
Failure To Sense | 2 |
Electrical /Electronic Property Problem | 2 |
Device Displays Incorrect Message | 2 |
No Apparent Adverse Event | 2 |
Appropriate Term/Code Not Available | 2 |
Insufficient Information | 1 |
Leak / Splash | 1 |
Device Emits Odor | 1 |
| Total Device Problems | 19 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | 3M Company - Health Care Business | II | Apr-24-2016 |
| 2 | 3M Company - Health Care Business | II | Apr-02-2014 |
| 3 | Advanced Sterilization Products | II | Dec-22-2014 |
| 4 | Advanced Sterilization Products | II | Jan-14-2014 |