Suture, Nonabsorbable, Synthetic, Polyamide

FDA product code GAR · 56 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.5020
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1990-07-05 – 2026-06-03

GAR 2026-06-03

Tissue Approximation System

Applicant Tas Medical, Inc.

K number K261484

View details →

GAR 2023-07-05

Tissue Approximation System (TAS)

Applicant Tas Medical, Inc.

K number K220980

View details →

GAR 2022-03-31

Golnit Nylon Monofilament Suture

Applicant Antarma, LLC Dba Golnit Sutures

K number K212888

View details →

GAR 2021-12-22

Non Absorbable Surgical Nylon Suture

Applicant Shandong Haidike Medical Product Co., Ltd.

K number K212603

View details →

GAR 2020-05-29

Crownjun Nylon Suture

Applicant Kono Seisakusho Co., Ltd.

K number K192420

View details →

GAR 2017-03-02

REXLON, REXSIL

Applicant Sm Eng Co., Ltd.

K number K161633

View details →

GAR 2016-02-17

Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture

Applicant Aesculap, Inc.

K number K151165

View details →

GAR 2013-05-28

VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED

Applicant Unilene Sac

K number K123034

View details →

GAR 2008-07-15

KUMAR T-ANCHORS HERNIA SET

Applicant Nashville Surgical Instruments

K number K081366

View details →

GAR 2006-07-26

FSSB NYLON SURGICAL SUTURES

Applicant Fssb Chirurgische Nadeln GmbH

K number K060471

View details →

GAR 2006-05-19

MANI NEEDLE & SUTURE PACK (NYLON)

Applicant Mani, Inc.

K number K053637

View details →

GAR 2006-03-28

AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE

Applicant Aesculap, Inc.

K number K060528

View details →

GAR 2005-11-28

QUILL NONABSORBABLE NYLON BARBED SUTURE

Applicant Quill Medical, Inc.

K number K052900

View details →

GAR 2005-10-17

ARTELON SURGICAL SUTURE

Applicant Artimplant AB

K number K052482

View details →

GAR 2005-06-02

TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE

Applicant Sutures India Private Limited

K number K041510

View details →

GAR 2004-12-03

UNIMIDE

Applicant United Medical Industries Co. , Ltd.

K number K042284

View details →

GAR 2004-10-14

NYLON THREADED NEEDLE

Applicant Aros Surgical Instruments Corp.

K number K042367

View details →

GAR 2003-11-17

ARTELON SURGICAL SUTURE

Applicant Artimplant AB

K number K032160

View details →

GAR 2003-09-23

S&T MICROSURGICAL SUTURE

Applicant S & T AG

K number K031531

View details →

GAR 2003-07-21

ORLON NONABSORABLE SURGICAL SUTURE USP

Applicant Sri Orion Pharmaceuticals & Sutures

K number K030177

View details →

GAR 2003-06-18

DEMETECH NYLON NONABSORBABLE SUTURE

Applicant Demetech Corp.

K number K023028

View details →

GAR 2003-02-28

NYLON SUTURE

Applicant Aurolab

K number K024090

View details →

GAR 2002-04-15

SERRALNYL

Applicant Serral, S.A. DE C.V.

K number K020146

View details →

GAR 2000-12-18

GRAMS NYLON NONABSORBABLE SUTURE

Applicant Gramsmed, LLC

K number K003000

View details →

GAR 2000-06-23

NYLON, NONABSORBABLE SURGICAL SUTURES USP

Applicant Cp Medical

K number K001173

View details →

GAR 2000-04-27

NYLON NONABSORBABLE SURGICAL SUTURES, USP

Applicant Arc Medical Supplies (Beijing) Co, Ltd.

K number K000539

View details →

GAR 2000-03-30

MICRINS MICROSURGICAL SUTURE

Applicant Micrins Surgical, Inc.

K number K993970

View details →

GAR 2000-02-08

SUTRALON NYLON SUTURES

Applicant Visionary Medical Supplies, Inc.

K number K994176

View details →

GAR 2000-02-04

NYLON

Applicant Trading Consultants and Distributors Intl., Inc.

K number K993998

View details →

GAR 1999-03-22

DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE

Applicant Aesculap, Inc.

K number K990090

View details →

GAR 1998-07-13

SURGILON, DERMALON, & OPHTHALON

Applicant Davis & Geck, Inc.

K number K981582

View details →

GAR 1998-07-07

CUTALON NYLON POLYAMIDE SURGICAL SUTURE

Applicant Genzyme Surgical Product (Genzyme Biosurgery)

K number K981322

View details →

GAR 1996-03-04

NYLON NOABSORBABLE SURGICAL SUTURES USP

Applicant R. K. Medical L. L. C.

K number K960327

View details →

GAR 1994-12-05

SURGIDEK B

Applicant Sutures , Ltd.

K number K943223

View details →

GAR 1994-12-05

SURGIDEK S

Applicant Sutures , Ltd.

K number K943222

View details →

GAR 1994-12-05

SURGIDEK

Applicant Sutures , Ltd.

K number K943216

View details →

GAR 1994-10-05

SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE

Applicant Surgimetrics International, Ltd.

K number K931914

View details →

GAR 1994-01-07

SUTURE ABSORBABLE- GUT

Applicant Surgical Specialties, Inc.

K number K932037

View details →

GAR 1993-12-17

SUPRAMID SUTURE

Applicant S. Jackson, Inc.

K number K931613

View details →

GAR 1993-12-17

NYLAMID SUTURE

Applicant S. Jackson, Inc.

K number K931612

View details →

GAR 1993-12-17

LUKENS NYLON SURGICAL SUTURE

Applicant Lukens Medical Corp.

K number K930943

View details →

GAR 1993-12-17

DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT

Applicant Davis & Geck, Inc.

K number K930586

View details →

GAR 1993-12-17

NON-ABSORBABLE SURGICAL SUTURES

Applicant Alcon Laboratories

K number K930517

View details →

GAR 1993-12-17

REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)

Applicant Look, Inc.

K number K926587

View details →

GAR 1993-12-17

SILK SUTURES-REVISED LABELING

Applicant Look, Inc.

K number K926168

View details →

GAR 1992-10-20

VISITEC MICROSURGICAL SUTURE

Applicant Visitec Co.

K number K922530

View details →

GAR 1992-09-14

URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER

Applicant Uresil Corp.

K number K920510

View details →

GAR 1992-08-03

PETERS CARDIONYL(TM) SUTURE

Applicant Promedica Products, Inc.

K number K913102

View details →

GAR 1991-10-02

N80-838 SUPRAMID EXTRA SUTURE

Applicant S. Jackson, Inc.

K number K912429

View details →

GAR 1991-06-28

ADVANCE SUTURE NONABSORBABLE NYLON SUTURE

Applicant Advance Suture, Inc.

K number K903177

View details →

GAR 1991-02-11

IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES

Applicant Internacional Farmaceutica, S.A. DE C.V.

K number K905286

View details →

GAR 1991-01-29

AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*

Applicant United States Surgical, A Division of Tyco Healthc

K number K904931

View details →

GAR 1991-01-17

AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP

Applicant United States Surgical, A Division of Tyco Healthc

K number K905379

View details →

GAR 1990-10-25

SUPRAMID EXTRA SUTURES

Applicant S. Jackson, Inc.

K number K904052

View details →

GAR 1990-10-25

STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE

Applicant Look, Inc.

K number K903029

View details →

GAR 1990-07-05

NONABSORBABLE NYLON SURGICAL SUTURE*

Applicant United States Surgical, A Division of Tyco Healthc

K number K900531

View details →