| Device Type ID | 2818 |
| Device Name | Apparatus, Exhaust, Surgical |
| Regulation Description | Air-handling Apparatus For A Surgical Operating Room. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.5070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FYD |
| 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 | 2818 |
| Device | Apparatus, Exhaust, Surgical |
| Product Code | FYD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Air-handling Apparatus For A Surgical Operating Room. |
| CFR Regulation Number | 878.5070 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BUFFALO FILTER CO., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LINA MEDICAL APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Electrical /Electronic Property Problem | 3 |
Device Remains Activated | 2 |
Self-Activation Or Keying | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Suction Problem | 2 |
Break | 2 |
Overheating Of Device | 1 |
No Audible Prompt / Feedback | 1 |
Partial Blockage | 1 |
Leak / Splash | 1 |
Unintended Power Up | 1 |
False Alarm | 1 |
Sparking | 1 |
| Total Device Problems | 20 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Microtek Medical Inc | II | Mar-27-2015 |
| 2 | Stryker Instruments Div. Of Stryker Corporation | II | Sep-01-2015 |
| 3 | Stryker Instruments Div. Of Stryker Corporation | II | Apr-24-2014 |