510(k) K212380

Device: PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
Applicant: ETHICON, Inc.
510(k) number: K212380
Product code: NEW
Decision: Substantially Equivalent (SESE)
Decision date: 2022-02-22
Date received: 2021-08-02
Regulation: 878.4840
Classification name: Suture, Surgical, Absorbable, Polydioxanone
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Marife Sevek
Address: 1000 Rte. 202 Raritan NJ US 08869 08869

FDA Registration Numbers

1614993
2528981
3006981798
3006680097
3003639970
3016560306
3012438919
3020983460
1054241
3016010820
3008868758
3006562124
3004117249
3018052045
1320468
1018470
1000274611
2125050
3027329031
3013589761
3015138222
3015289316
3017102971
3013403214
3015812758
1055236
3016244792
1221601
3023274465
3003267729
3010864832
3002294946
3010692967
1221934
3011555199
3003828812
3010462274
3016445763
3014273254
3043226252
3004365956
3013187142
3029901632
3030733800
3007205024
3016904853
3038138322
1043214
2246552
2210968
3013354263
3013298431
2648650
3004845555
3017936846
3005972890
3008114965
9617547
3013376016
3010131137
1064584
3012494290
3014527910
3014461810
3010041511
2650143
2183744
3014615644
3007791599
3014272734
3012502601
3004944585
3007895168
1721676
3006638824
2030624
3005953126
3011137372
3012421607
3008912461

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code NEW

510(k)	Device	Applicant	Decision date
K252047	STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices	ETHICON, Inc.	2026-05-18
K243897	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture	ETHICON, Inc.	2025-11-12
K251414	Miracu Polydioxanone (PDO) Suture and Needle (MONO)	Feeltech Co., Ltd.	2025-10-20
K250107	V-soft Line Barbed Surgical Suture (Various)	Feeltech Co., Ltd.	2025-10-15
K252644	PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture	M/s. Meril Endo Surgery Private Limited.	2025-09-23
K250977	Suture-TOOL System	Suturion AB	2025-04-28
K242835	Suture-TOOL System	Suturion AB	2025-01-22
K242571	Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938	Hyundae Meditech Co., Ltd.	2024-09-27
K232246	1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture	M/s. Meril Endo Surgery Private Limited.	2024-04-25
K240389	Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)	Hyundae Meditech Co., Ltd.	2024-03-27
K220549	MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014	Hans Biomed Corporation	2023-03-07
K210871	PDO Max Suture with Dual Needle	Pdo Max, Inc.	2021-12-17
K201139	WEGO-PDO Barbed Suture	Foosin Medical Supplies Inc., Ltd.	2020-10-20
K192423	MINT Product Family	Hans Biomed Corporation	2020-09-09
K192144	STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device	ETHICON, Inc.	2020-03-25