| Device Type ID | 5598 |
| Device Name | Suture, Nonabsorbable, Silk |
| Regulation Description | Natural Nonabsorbable Silk Surgical 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 | 878.5030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GAP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5598 |
| Device | Suture, Nonabsorbable, Silk |
| Product Code | GAP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Natural Nonabsorbable Silk Surgical Suture. |
| CFR Regulation Number | 878.5030 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TELEFLEX MEDICAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 241 |
Adverse Event Without Identified Device Or Use Problem | 48 |
Detachment Of Device Component | 31 |
Detachment Of Device Or Device Component | 30 |
Material Separation | 28 |
Appropriate Term/Code Not Available | 21 |
Unsealed Device Packaging | 13 |
Component Incompatible | 7 |
Manufacturing, Packaging Or Shipping Problem | 7 |
Product Quality Problem | 6 |
Material Integrity Problem | 6 |
Device Operates Differently Than Expected | 6 |
Tear, Rip Or Hole In Device Packaging | 4 |
Knotted | 4 |
Dull, Blunt | 3 |
Material Twisted / Bent | 3 |
Material Frayed | 3 |
Incorrect Device Or Component Shipped | 2 |
Device Issue | 2 |
Material Fragmentation | 1 |
Out-Of-Box Failure | 1 |
Poor Quality Image | 1 |
Entrapment Of Device | 1 |
Loose Or Intermittent Connection | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Defective Device | 1 |
Delivered As Unsterile Product | 1 |
Component Missing | 1 |
Physical Property Issue | 1 |
Device Operational Issue | 1 |
Bent | 1 |
Migration Or Expulsion Of Device | 1 |
Patient-Device Incompatibility | 1 |
Failure To Adhere Or Bond | 1 |
| Total Device Problems | 480 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ethicon, Inc. | II | Jan-16-2019 |
| 2 | Ethicon, Inc. | II | Jan-09-2015 |
| 3 | Teleflex Medical | II | May-07-2014 |