| Device Type ID | 5639 |
| Device Name | Gauze/sponge, Internal, X-ray Detectable |
| Regulation Description | Nonabsorbable Gauze For Internal Use. |
| 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 | 878.4450 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GDY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5639 |
| Device | Gauze/sponge, Internal, X-ray Detectable |
| Product Code | GDY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonabsorbable Gauze For Internal Use. |
| CFR Regulation Number | 878.4450 [🔎] |
| Device Problems | |
|---|---|
Material Frayed | 126 |
Material Fragmentation | 110 |
Incomplete Or Missing Packaging | 76 |
Material Separation | 59 |
Packaging Problem | 53 |
Particulates | 43 |
Detachment Of Device Component | 42 |
Material Integrity Problem | 27 |
Device Packaging Compromised | 15 |
Component Missing | 13 |
Appropriate Term/Code Not Available | 12 |
Material Disintegration | 11 |
Detachment Of Device Or Device Component | 8 |
Device Contamination With Chemical Or Other Material | 7 |
Unraveled Material | 7 |
Flaked | 6 |
Device Misassembled During Manufacturing / Shipping | 5 |
Manufacturing, Packaging Or Shipping Problem | 4 |
Break | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Device Operates Differently Than Expected | 3 |
Product Quality Problem | 3 |
Defective Component | 3 |
Delivered As Unsterile Product | 2 |
Disassembly | 2 |
Torn Material | 2 |
Material Deformation | 2 |
False Negative Result | 2 |
Unsealed Device Packaging | 1 |
Device-Device Incompatibility | 1 |
Sticking | 1 |
Thread | 1 |
Nonstandard Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Component Falling | 1 |
Short Fill | 1 |
Explanted | 1 |
Incorrect Measurement | 1 |
Degraded | 1 |
Misassembled | 1 |
Device Sensing Problem | 1 |
| Total Device Problems | 663 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | American Surgical Company | II | May-26-2016 |
| 2 | Covidien LLC | II | Mar-19-2018 |
| 3 | Covidien LP | II | Feb-08-2018 |
| 4 | Medical Action Industries Inc | II | Mar-28-2019 |
| 5 | Medical Action Industries Inc | II | Dec-22-2018 |
| 6 | Medical Action Industries Inc | II | May-17-2017 |
| 7 | Rainbow Specialty & Health Products | II | Dec-23-2015 |