| Device Type ID | 5602 |
| Device Name | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Regulation Description | Nonabsorbable Poly(ethylene Terephthalate) 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 | 878.5000 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GAT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5602 |
| Device | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Product Code | GAT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nonabsorbable Poly(ethylene Terephthalate) Surgical Suture. |
| CFR Regulation Number | 878.5000 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED MEDICAL SOLUTIONS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALLOSOURCE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANCHOR INNOVATION MEDICAL (A.I.M.) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARTHREX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ARTHROCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAYLIS MEDICAL COMPANY INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CETERIX ORTHOPAEDICS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDOS INTERNATIONAL SARL | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDTRONIC XOMED INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MUSCULOSKELETAL TRANSPLANT FOUNDATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RIVERPOINT MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SENTREHEART INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITH & NEPHEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
TELEFLEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
WRIGHT MEDICAL TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XIROS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 437 |
Appropriate Term/Code Not Available | 114 |
Detachment Of Device Component | 100 |
Adverse Event Without Identified Device Or Use Problem | 85 |
Detachment Of Device Or Device Component | 70 |
Material Separation | 35 |
Positioning Failure | 28 |
Tear, Rip Or Hole In Device Packaging | 28 |
Device Operates Differently Than Expected | 27 |
Misfire | 24 |
Activation, Positioning Or Separation Problem | 24 |
Migration Or Expulsion Of Device | 21 |
Device Dislodged Or Dislocated | 15 |
Material Frayed | 15 |
Component Falling | 14 |
Premature Activation | 13 |
Material Split, Cut Or Torn | 12 |
Use Of Device Problem | 11 |
Failure To Adhere Or Bond | 10 |
Device Markings / Labelling Problem | 10 |
Unsealed Device Packaging | 10 |
Loose Or Intermittent Connection | 9 |
Packaging Problem | 9 |
Failure To Fire | 9 |
Material Integrity Problem | 8 |
Device Misassembled During Manufacturing / Shipping | 7 |
Loosening Of Implant Not Related To Bone-Ingrowth | 6 |
Switch, Push Button | 6 |
Bent | 6 |
Patient-Device Incompatibility | 6 |
Component Missing | 6 |
Improper Or Incorrect Procedure Or Method | 5 |
Sticking | 5 |
Patient Device Interaction Problem | 4 |
Material Fragmentation | 4 |
Insufficient Information | 4 |
Separation Problem | 4 |
Human-Device Interface Problem | 4 |
Difficult To Open Or Close | 4 |
Unraveled Material | 4 |
Difficult Or Delayed Positioning | 3 |
Self-Activation Or Keying | 3 |
No Apparent Adverse Event | 3 |
Difficult To Remove | 3 |
Migration | 3 |
Failure To Align | 3 |
Split | 3 |
Defective Device | 3 |
Positioning Problem | 3 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Component Incompatible | 3 |
Battery Charger, Defective | 3 |
Device Subassembly | 3 |
Incorrect Device Or Component Shipped | 2 |
Device Issue | 2 |
Device Packaging Compromised | 2 |
Plunger | 2 |
Mechanical Problem | 2 |
Expiration Date Error | 2 |
Suture | 2 |
Retraction Problem | 2 |
Physical Property Issue | 2 |
Jaw | 2 |
Coiled | 1 |
Delivered As Unsterile Product | 1 |
Component Misassembled | 1 |
Structural Problem | 1 |
Loss Of Or Failure To Bond | 1 |
Degraded | 1 |
Device Difficult To Setup Or Prepare | 1 |
Material Twisted / Bent | 1 |
Material Disintegration | 1 |
Product Quality Problem | 1 |
Device Inoperable | 1 |
Unstable | 1 |
Device Contamination With Body Fluid | 1 |
Difficult To Position | 1 |
Needle | 1 |
Thread | 1 |
Device Or Device Fragments Location Unknown | 1 |
Device Slipped | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Cut In Material | 1 |
Mechanics Altered | 1 |
Dull, Blunt | 1 |
Entrapment Of Device | 1 |
Material Erosion | 1 |
Flaked | 1 |
Difficult To Insert | 1 |
Device Handling Problem | 1 |
Human Factors Issue | 1 |
Mechanical Jam | 1 |
Failure To Form Staple | 1 |
Out-Of-Box Failure | 1 |
Incomplete Or Missing Packaging | 1 |
Plate | 1 |
Material Deformation | 1 |
Device-Device Incompatibility | 1 |
| Total Device Problems | 1307 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Peters Surgical | II | Sep-22-2014 |
| 2 | Smith & Nephew, Inc. | II | Jun-22-2015 |
| 3 | Teleflex Medical | II | May-07-2014 |
| 4 | Teleflex Medical | II | Mar-26-2014 |