Suture, Surgical, Absorbable, Polydioxanone

Device Code: 5764

Product Code(s): NEW

Device Type ID	5764
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Regulation Description	Absorbable Polydioxanone 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	878.4840 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	NEW
GMP Exempt	No
Summary MR	Eligible
Implanted Device	Yes
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	5764
Device	Suture, Surgical, Absorbable, Polydioxanone
Product Code	NEW
FDA Device Classification	Class 2 Medical Device
Regulation Description	Absorbable Polydioxanone Surgical Suture.
CFR Regulation Number	878.4840 [🔎]

Premarket Reviews
Manufacturer	Decision
ETHICON
	SUBSTANTIALLY EQUIVALENT - WITH DRUG	1
	SUBSTANTIALLY EQUIVALENT	2
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT - WITH DRUG	1
	SUBSTANTIALLY EQUIVALENT	2
FEELTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MYCO MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	975
Appropriate Term/Code Not Available	272
Detachment Of Device Component	175
Failure To Adhere Or Bond	109
Material Separation	98
Adverse Event Without Identified Device Or Use Problem	54
Detachment Of Device Or Device Component	39
Tear, Rip Or Hole In Device Packaging	38
Material Integrity Problem	18
Component Incompatible	17
Material Frayed	14
No Apparent Adverse Event	12
Bent	8
Positioning Problem	8
Kinked	7
Defective Device	7
Battery Charger, Defective	6
Out-Of-Box Failure	5
Migration Or Expulsion Of Device	5
Product Quality Problem	5
Loss Of Or Failure To Bond	5
Device Misassembled During Manufacturing / Shipping	4
Incorrect Device Or Component Shipped	4
Packaging Problem	4
Difficult To Open Or Remove Packaging Material	3
Loose Or Intermittent Connection	3
Dull, Blunt	3
Material Fragmentation	3
Component Missing	3
Device Operates Differently Than Expected	3
Material Twisted / Bent	3
Fracture	2
Defective Component	2
Material Split, Cut Or Torn	2
Unsealed Device Packaging	2
Leak / Splash	2
Device Markings / Labelling Problem	2
Manufacturing, Packaging Or Shipping Problem	2
Failure To Unfold Or Unwrap	2
Other (for Use When An Appropriate Device Code Cannot Be Identified)	2
Nonstandard Device	1
Knotted	1
Incomplete Or Missing Packaging	1
Device Issue	1
Mechanical Jam	1
Disassembly	1
Melted	1
Misassembled	1
Suture	1
Total Device Problems	1937

TPLC Last Update: 2019-04-02 21:12:09