| Device Type ID | 5600 |
| Device Name | Suture, Nonabsorbable, Synthetic, Polyamide |
| Regulation Description | Nonabsorbable Polyamide 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) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.5020 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GAR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5600 |
| Device | Suture, Nonabsorbable, Synthetic, Polyamide |
| Product Code | GAR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nonabsorbable Polyamide Surgical Suture. |
| CFR Regulation Number | 878.5020 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RIVERPOINT MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 522 |
Appropriate Term/Code Not Available | 77 |
Detachment Of Device Component | 67 |
Material Separation | 62 |
Adverse Event Without Identified Device Or Use Problem | 50 |
Detachment Of Device Or Device Component | 47 |
Failure To Adhere Or Bond | 41 |
Device Markings / Labelling Problem | 22 |
Product Quality Problem | 17 |
Bent | 17 |
Manufacturing, Packaging Or Shipping Problem | 15 |
Device Misassembled During Manufacturing / Shipping | 14 |
Material Integrity Problem | 12 |
Patient-Device Incompatibility | 11 |
Device Operates Differently Than Expected | 10 |
Tear, Rip Or Hole In Device Packaging | 9 |
Material Frayed | 7 |
Unsealed Device Packaging | 7 |
Packaging Problem | 6 |
Component Incompatible | 4 |
Knotted | 3 |
Crack | 3 |
Device Damaged Prior To Use | 3 |
Dull, Blunt | 3 |
Material Split, Cut Or Torn | 3 |
Fracture | 3 |
Material Twisted / Bent | 2 |
Defective Component | 2 |
Material Discolored | 2 |
Misassembled | 2 |
Nonstandard Device | 2 |
Needle, Separation | 2 |
Battery Charger, Defective | 2 |
Incomplete Or Missing Packaging | 2 |
Material Too Rigid Or Stiff | 2 |
Out-Of-Box Failure | 1 |
Inaccurate Information | 1 |
Incorrect Device Or Component Shipped | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Poor Quality Image | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Needle | 1 |
Thread | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Kinked | 1 |
Reaction | 1 |
Material Rupture | 1 |
Delivered As Unsterile Product | 1 |
Occlusion Within Device | 1 |
Unraveled Material | 1 |
Label | 1 |
Loss Of Or Failure To Bond | 1 |
Component Missing | 1 |
Tip | 1 |
| Total Device Problems | 1074 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aesculap, Inc. | II | Jul-09-2014 |
| 2 | Riverpoint Medical, LLC | II | Sep-08-2016 |
| 3 | Teleflex Medical | II | May-07-2014 |