| Device Type ID | 5623 |
| Device Name | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Regulation Description | Nonpowered, Single Patient, Portable Suction Apparatus. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| 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) Exempt |
| CFR Regulation Number | 878.4680 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GCY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5623 |
| Device | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Product Code | GCY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonpowered, Single Patient, Portable Suction Apparatus. |
| CFR Regulation Number | 878.4680 [🔎] |
| Device Problems | |
|---|---|
Suction Problem | 65 |
Break | 42 |
Device Inoperable | 17 |
Disconnection | 11 |
Device Contamination With Chemical Or Other Material | 6 |
Leak / Splash | 5 |
Burst Container Or Vessel | 4 |
Device Operates Differently Than Expected | 4 |
Improper Flow Or Infusion | 3 |
Crack | 2 |
Fluid Leak | 2 |
Nonstandard Device | 2 |
Decrease In Suction | 2 |
Fitting Problem | 2 |
Partial Blockage | 2 |
Detachment Of Device Component | 2 |
Air Leak | 2 |
Material Fragmentation | 2 |
Material Separation | 1 |
Device Issue | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Device Damaged Prior To Use | 1 |
Dull, Blunt | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Collapse | 1 |
Fracture | 1 |
Difficult To Remove | 1 |
Product Quality Problem | 1 |
Obstruction Of Flow | 1 |
No Flow | 1 |
Appropriate Term/Code Not Available | 1 |
Loss Of Or Failure To Bond | 1 |
Misassembled | 1 |
Delivered As Unsterile Product | 1 |
Occlusion Within Device | 1 |
| Total Device Problems | 193 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aspen Surgical Products, Inc. | II | Apr-07-2014 |
| 2 | COVIDIEN LLC | II | Dec-21-2018 |
| 3 | Cardinal Health 200, LLC | II | May-23-2017 |
| 4 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 5 | Intuitive Surgical, Inc. | II | May-27-2016 |
| 6 | Stryker Instruments Div. Of Stryker Corporation | II | May-01-2015 |
| 7 | Stryker Leibinger GmbH & Co. KG | II | Feb-08-2017 |
| 8 | Zimmer Surgical Inc | III | May-13-2015 |