| Device Type ID | 2610 |
| Device Name | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Regulation Description | Vacuum-powered Body Fluid Suction Apparatus. |
| 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) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.6740 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GCX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2610 |
| Device | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Product Code | GCX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vacuum-powered Body Fluid Suction Apparatus. |
| CFR Regulation Number | 880.6740 [🔎] |
| Device Problems | |
|---|---|
Suction Problem | 21 |
Device Contamination With Chemical Or Other Material | 19 |
Tube | 13 |
Out-Of-Box Failure | 11 |
Crack | 9 |
Device Packaging Compromised | 7 |
Material Fragmentation | 5 |
Break | 4 |
Tear, Rip Or Hole In Device Packaging | 4 |
Appropriate Term/Code Not Available | 3 |
Detachment Of Device Component | 3 |
Leak / Splash | 2 |
Packaging Problem | 2 |
Delivered As Unsterile Product | 2 |
Obstruction Of Flow | 1 |
Device Dislodged Or Dislocated | 1 |
Device Inoperable | 1 |
Burst Container Or Vessel | 1 |
Device Operates Differently Than Expected | 1 |
Infusion Or Flow Problem | 1 |
Decrease In Suction | 1 |
Kinked | 1 |
Chemical Spillage | 1 |
Hole In Material | 1 |
| Total Device Problems | 115 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cardinal Health 200, LLC | II | Apr-30-2018 |
| 2 | Hospira Inc. | II | Aug-18-2016 |
| 3 | Stryker Corporation | II | Mar-02-2018 |