| Device Type ID | 5594 |
| Device Name | Suture, Absorbable, Natural |
| Regulation Description | Absorbable Surgical Gut Suture. |
| 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) |
| CFR Regulation Number | 878.4830 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GAL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5594 |
| Device | Suture, Absorbable, Natural |
| Product Code | GAL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Absorbable Surgical Gut Suture. |
| CFR Regulation Number | 878.4830 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 313 |
Appropriate Term/Code Not Available | 46 |
Fluid Leak | 45 |
Detachment Of Device Component | 33 |
Material Frayed | 32 |
Leak / Splash | 29 |
Detachment Of Device Or Device Component | 25 |
Material Integrity Problem | 21 |
Material Separation | 18 |
Failure To Adhere Or Bond | 16 |
Adverse Event Without Identified Device Or Use Problem | 15 |
Device Operates Differently Than Expected | 11 |
Material Too Rigid Or Stiff | 11 |
Packaging Problem | 9 |
Manufacturing, Packaging Or Shipping Problem | 9 |
Difficult To Open Or Close | 7 |
Knotted | 6 |
Defective Device | 5 |
Material Twisted / Bent | 5 |
Product Quality Problem | 5 |
Bent | 4 |
Crack | 4 |
Device Markings / Labelling Problem | 4 |
Needle | 3 |
Thread | 3 |
Incorrect Device Or Component Shipped | 3 |
Unsealed Device Packaging | 3 |
Tip | 3 |
Difficult To Remove | 2 |
Component Incompatible | 2 |
Material Fragmentation | 2 |
Device Issue | 2 |
Material Deformation | 2 |
Torn Material | 2 |
Loose Or Intermittent Connection | 2 |
Mechanics Altered | 2 |
Material Rupture | 1 |
Dull, Blunt | 1 |
Entrapment Of Device | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Mechanical Problem | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Incorrect Or Inadequate Test Results | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Out-Of-Box Failure | 1 |
Expiration Date Error | 1 |
Material Disintegration | 1 |
Migration Or Expulsion Of Device | 1 |
Defective Component | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Material Discolored | 1 |
Degraded | 1 |
Component Missing | 1 |
Coiled | 1 |
Difficult Or Delayed Positioning | 1 |
Delivered As Unsterile Product | 1 |
Unraveled Material | 1 |
Misfire | 1 |
| Total Device Problems | 727 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CP Medical Inc | II | Mar-19-2019 |
| 2 | Ethicon, Inc. | II | Jun-25-2015 |