| Device Type ID | 5599 |
| Device Name | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Regulation Description | Stainless Steel 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 | 878.4495 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GAQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5599 |
| Device | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Product Code | GAQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stainless Steel Suture. |
| CFR Regulation Number | 878.4495 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DEMETECH CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PONTIS ORTHOPAEDICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 43 |
Appropriate Term/Code Not Available | 17 |
Detachment Of Device Or Device Component | 11 |
Adverse Event Without Identified Device Or Use Problem | 7 |
Bent | 5 |
Material Twisted / Bent | 3 |
Failure To Adhere Or Bond | 3 |
Detachment Of Device Component | 3 |
Incorrect Device Or Component Shipped | 3 |
Device Maintenance Issue | 2 |
Material Separation | 2 |
Device Markings / Labelling Problem | 2 |
Packaging Problem | 1 |
Difficult To Position | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Device Or Device Fragments Location Unknown | 1 |
Device Operates Differently Than Expected | 1 |
Difficult Or Delayed Positioning | 1 |
| Total Device Problems | 107 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Teleflex Medical | II | May-07-2014 |
| 2 | Teleflex Medical | II | Apr-24-2014 |