| Device Type ID | 5704 |
| Device Name | Tourniquet, Pneumatic |
| Regulation Description | Pneumatic Tourniquet. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.5910 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KCY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5704 |
| Device | Tourniquet, Pneumatic |
| Product Code | KCY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Pneumatic Tourniquet. |
| CFR Regulation Number | 878.5910 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TERUMO BCT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Air Leak | 78 |
Pressure Problem | 72 |
Decrease In Pressure | 30 |
Leak / Splash | 28 |
Gas Leak | 19 |
Deflation Problem | 16 |
Inflation Problem | 9 |
Device Operates Differently Than Expected | 9 |
Device Contaminated During Manufacture Or Shipping | 5 |
Device Emits Odor | 5 |
Appropriate Term/Code Not Available | 4 |
Increase In Pressure | 4 |
Cut In Material | 3 |
Insufficient Information | 3 |
Noise, Audible | 2 |
Break | 2 |
Fluid Leak | 2 |
Split | 2 |
Torn Material | 2 |
Device Alarm System | 2 |
Hole In Material | 2 |
Material Torqued | 2 |
Device Displays Incorrect Message | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Material Split, Cut Or Torn | 2 |
Use Of Device Problem | 2 |
Battery Problem | 2 |
Display Difficult To Read | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Burst Container Or Vessel | 1 |
Incorrect Measurement | 1 |
Smoking | 1 |
Cuff | 1 |
Electrical /Electronic Property Problem | 1 |
Device Issue | 1 |
Image Display Error / Artifact | 1 |
Improper Alarm | 1 |
Thermal Decomposition Of Device | 1 |
Material Rupture | 1 |
Defective Device | 1 |
Calibration Problem | 1 |
| Total Device Problems | 325 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | STERILMED, INC. | II | Dec-10-2015 |
| 2 | STERILMED, INC. | II | Sep-28-2015 |
| 3 | Stryker Instruments Div. Of Stryker Corporation | II | Jan-06-2014 |
| 4 | Stryker Sustainability Solutions | II | Oct-28-2016 |
| 5 | Stryker Sustainability Solutions | II | Jan-12-2016 |
| 6 | Zimmer Surgical Inc | II | Feb-14-2018 |
| 7 | Zimmer Surgical Inc | II | Aug-06-2015 |