| Device Type ID | 5471 |
| Device Name | Counter, Sponge, Surgical |
| Regulation Description | Surgical Sponge Scale. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.2740 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LWH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5471 |
| Device | Counter, Sponge, Surgical |
| Product Code | LWH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Sponge Scale. |
| CFR Regulation Number | 880.2740 [🔎] |
| Device Problems | |
|---|---|
False Positive Result | 116 |
False Negative Result | 54 |
Device Displays Incorrect Message | 6 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Particulates | 5 |
Material Frayed | 2 |
False Reading From Device Non-Compliance | 2 |
Failure To Power Up | 2 |
Material Separation | 1 |
Installation-Related Problem | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Calibration Error | 1 |
Computer Software Problem | 1 |
Unable To Obtain Readings | 1 |
Defective Device | 1 |
Output Problem | 1 |
Communication Or Transmission Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Defective Component | 1 |
Material Integrity Problem | 1 |
Unraveled Material | 1 |
Connection Problem | 1 |
Intermittent Energy Output | 1 |
| Total Device Problems | 208 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Instruments Div. Of Stryker Corporation | II | Apr-13-2016 |
| 2 | Stryker Instruments Div. Of Stryker Corporation | II | Jan-15-2015 |