Suture, Nonabsorbable, Synthetic, Polypropylene

Device Code: 5603

Product Code(s): GAW

Device Classification Information

Device Type ID5603
Device NameSuture, Nonabsorbable, Synthetic, Polypropylene
Regulation DescriptionNonabsorbable Polypropylene Surgical Suture.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(k)
CFR Regulation Number878.5010 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGAW
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5603
DeviceSuture, Nonabsorbable, Synthetic, Polypropylene
Product CodeGAW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionNonabsorbable Polypropylene Surgical Suture.
CFR Regulation Number878.5010 [🔎]
Premarket Reviews
ManufacturerDecision
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
TPLC Last Update: 2019-04-02 21:09:16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.