| Device Type ID | 5603 |
| Device Name | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Regulation Description | Nonabsorbable Polypropylene 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 | 878.5010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GAW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5603 |
| Device | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Product Code | GAW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nonabsorbable Polypropylene Surgical Suture. |
| CFR Regulation Number | 878.5010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED MEDICAL SOLUTIONS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ANGIOTECH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ASSUT EUROPE S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEARTSTITCH, INC. | ||
SE - WITH LIMITATIONS | 1 | |
ORIGAMI SURGICAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SILHOUETTE LIFT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 742 |
Failure To Adhere Or Bond | 371 |
Detachment Of Device Or Device Component | 207 |
Appropriate Term/Code Not Available | 113 |
Material Integrity Problem | 63 |
Material Frayed | 62 |
Detachment Of Device Component | 59 |
Adverse Event Without Identified Device Or Use Problem | 48 |
Bent | 27 |
Device Markings / Labelling Problem | 24 |
Material Separation | 20 |
Device Operates Differently Than Expected | 20 |
Battery Charger, Defective | 19 |
Split | 17 |
Tear, Rip Or Hole In Device Packaging | 17 |
Fracture | 16 |
Unsealed Device Packaging | 14 |
Component Incompatible | 13 |
Product Quality Problem | 13 |
Knotted | 10 |
Needle | 9 |
Dull, Blunt | 8 |
Material Split, Cut Or Torn | 8 |
Migration Or Expulsion Of Device | 7 |
Crack | 7 |
Packaging Problem | 6 |
Insufficient Information | 5 |
Mechanical Problem | 5 |
Difficult To Open Or Remove Packaging Material | 5 |
Material Deformation | 5 |
Component Missing | 5 |
Unraveled Material | 5 |
Coiled | 4 |
Material Twisted / Bent | 4 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 4 |
Manufacturing, Packaging Or Shipping Problem | 4 |
Loose Or Intermittent Connection | 3 |
Separation Problem | 3 |
Leak / Splash | 3 |
Device Misassembled During Manufacturing / Shipping | 3 |
Incorrect Device Or Component Shipped | 3 |
Suture | 3 |
Difficult To Remove | 3 |
Misassembled | 3 |
Difficult Or Delayed Positioning | 2 |
Tip | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Material Fragmentation | 2 |
Thread | 2 |
Device Or Device Fragments Location Unknown | 2 |
Kinked | 2 |
Difficult To Insert | 1 |
Material Rupture | 1 |
Device Damaged Prior To Use | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Difficult To Position | 1 |
Device Slipped | 1 |
Stretched | 1 |
Torn Material | 1 |
Material Too Soft / Flexible | 1 |
Material Too Rigid Or Stiff | 1 |
Incomplete Or Missing Packaging | 1 |
Device Issue | 1 |
Material Protrusion / Extrusion | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Device Maintenance Issue | 1 |
Difficult To Open Or Close | 1 |
Physical Property Issue | 1 |
Loss Of Or Failure To Bond | 1 |
Device Difficult To Setup Or Prepare | 1 |
Material Disintegration | 1 |
Human-Device Interface Problem | 1 |
Tip Breakage | 1 |
Defective Component | 1 |
Solder Joint Fracture | 1 |
| Total Device Problems | 2028 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ethicon, Inc. | II | Jul-17-2018 |
| 2 | SSC- Surgical Specialties Corporation | II | Jun-21-2016 |