| Device Type ID | 5595 |
| Device Name | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Regulation Description | Absorbable Poly(glycolide/l-lactide) 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 | 878.4493 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GAM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5595 |
| Device | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Product Code | GAM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Absorbable Poly(glycolide/l-lactide) Surgical Suture. |
| CFR Regulation Number | 878.4493 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED MEDICAL SOLUTIONS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AUROLAB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEMETECH CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
ETHICON, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
ETHICON, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORIGAMI SURGICAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SILHOUETTE LIFT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SURGICAL SPECIALTIES CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SURGICAL SPECIALTIES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WEIGAO GROUP COMPANY LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Break | 2003 |
Appropriate Term/Code Not Available | 872 |
Detachment Of Device Or Device Component | 795 |
Adverse Event Without Identified Device Or Use Problem | 402 |
Failure To Adhere Or Bond | 382 |
Detachment Of Device Component | 321 |
Material Integrity Problem | 174 |
Unraveled Material | 110 |
Bent | 108 |
Patient-Device Incompatibility | 95 |
Device Operates Differently Than Expected | 95 |
Product Quality Problem | 87 |
Migration Or Expulsion Of Device | 67 |
Loss Of Or Failure To Bond | 67 |
Packaging Problem | 65 |
Degraded | 47 |
Device Markings / Labelling Problem | 46 |
Device Misassembled During Manufacturing / Shipping | 43 |
Tear, Rip Or Hole In Device Packaging | 42 |
Human-Device Interface Problem | 39 |
Manufacturing, Packaging Or Shipping Problem | 35 |
Insufficient Information | 32 |
Material Frayed | 31 |
Component Missing | 30 |
Material Fragmentation | 28 |
Loose Or Intermittent Connection | 25 |
Component Incompatible | 23 |
Material Separation | 23 |
Fracture | 23 |
Needle | 21 |
Defective Device | 20 |
Dull, Blunt | 20 |
Material Twisted / Bent | 20 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 19 |
Absorption | 18 |
Device Or Device Fragments Location Unknown | 16 |
Device Packaging Compromised | 16 |
Material Disintegration | 16 |
Material Split, Cut Or Torn | 15 |
Extrusion | 15 |
Material Deformation | 14 |
Thread | 14 |
Reaction | 14 |
Battery Charger, Defective | 13 |
Knotted | 13 |
Material Too Soft / Flexible | 11 |
Mechanical Problem | 11 |
Device Slipped | 11 |
No Apparent Adverse Event | 11 |
Failure To Unwrap | 10 |
Difficult To Open Or Remove Packaging Material | 10 |
Naturally Worn | 10 |
Device Issue | 9 |
Out-Of-Box Failure | 8 |
Incomplete Or Missing Packaging | 8 |
Label | 7 |
Defective Component | 7 |
Failure To Fire | 6 |
Unsealed Device Packaging | 6 |
Difficult To Position | 6 |
Component Falling | 6 |
Entrapment Of Device | 5 |
Nonstandard Device | 5 |
Difficult To Remove | 5 |
Delivered As Unsterile Product | 4 |
Component Misassembled | 4 |
Physical Property Issue | 4 |
Expulsion | 4 |
Incorrect Device Or Component Shipped | 4 |
Device Contaminated During Manufacture Or Shipping | 3 |
Sticking | 3 |
Component Or Accessory Incompatibility | 3 |
Split | 3 |
Material Erosion | 3 |
Cross Reactivity | 3 |
Device Disinfection Or Sterilization Issue | 3 |
Mechanics Altered | 3 |
Device Damaged Prior To Use | 3 |
Use Of Device Problem | 3 |
Difficult To Open Or Close | 3 |
Difficult Or Delayed Positioning | 3 |
Suture | 3 |
Compatibility Problem | 3 |
Device Appears To Trigger Rejection | 3 |
Unexpected Therapeutic Results | 2 |
Misassembled | 2 |
Fluid Leak | 2 |
Torn Material | 2 |
Cut In Material | 2 |
Material Too Rigid Or Stiff | 2 |
Poor Quality Image | 2 |
Needle, Separation | 1 |
Leak / Splash | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Off-Label Use | 1 |
Folded | 1 |
Material Protrusion / Extrusion | 1 |
Mechanical Jam | 1 |
Patient Device Interaction Problem | 1 |
Inaccurate Information | 1 |
| Total Device Problems | 6614 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aesculap Implant Systems LLC | II | Oct-26-2016 |
| 2 | CP Medical Inc | II | Apr-20-2017 |
| 3 | Covidien LLC | II | Aug-03-2018 |
| 4 | Ethicon, Inc. | II | Feb-23-2018 |
| 5 | Medtronic | II | Jun-14-2017 |
| 6 | Silhouette Lift, Inc. | II | Jul-23-2015 |
| 7 | Teleflex Medical | II | May-07-2014 |
| 8 | Teleflex Medical | II | May-01-2014 |