| Device Type ID | 2539 |
| Device Name | Sterilizer, Steam |
| Regulation Description | Steam 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 | 880.6880 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FLE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2539 |
| Device | Sterilizer, Steam |
| Product Code | FLE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Steam Sterilizer. |
| CFR Regulation Number | 880.6880 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BELIMED AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CEFLA S.C. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FORT DEFIANCE INDUSTRIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MIDMARK CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MIDMARK CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MILTON E PEDRAZZI D.D.S., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
REVOLUTIONARY SCIENCE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAKURA GLOBAL HOLDING COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAUTER AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
TUTTNAUER USA CO. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
W&H STERILIZATION S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Adhere Or Bond | 12 |
Device Operates Differently Than Expected | 7 |
Seal | 3 |
Use Of Device Problem | 2 |
Residue After Decontamination | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Leak / Splash | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Human Factors Issue | 2 |
Device Disinfection Or Sterilization Issue | 2 |
Moisture Or Humidity Problem | 1 |
Scratched Material | 1 |
Component Falling | 1 |
Material Erosion | 1 |
Loose Or Intermittent Connection | 1 |
Fluid Leak | 1 |
Missing Value Reason | 1 |
Device Issue | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Unintended Movement | 1 |
Unstable | 1 |
Gas Leak | 1 |
Device Reprocessing Problem | 1 |
Problem With Sterilization | 1 |
Sparking | 1 |
Material Split, Cut Or Torn | 1 |
| Total Device Problems | 52 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Fort Defiance Industries, LLC | II | Jul-10-2018 |
| 2 | Steris Corporation | II | Feb-13-2019 |
| 3 | Steris Corporation | III | Nov-04-2015 |
| 4 | Steris Corporation | II | Apr-30-2015 |