Suture, Nonabsorbable, Silk

FDA product code GAP · 41 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.5030
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-19 – 2024-12-03

GAP 2024-12-03

Sofsilk™ Coated Braided Silk Suture

Applicant Covidien

K number K241486

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GAP 2024-10-18

SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture

Applicant Safepath Medical, Inc.

K number K222944

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GAP 2024-01-16

Non absorbable Surgical Silk Suture

Applicant Shandong Haidike Medical Product Co., Ltd.

K number K232355

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GAP 2023-07-31

Surgical Sutures with or without Needle

Applicant Huaian Seamen Medical Technology Co., Ltd.

K number K221767

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GAP 2018-06-25

SafePath Suturing System

Applicant Safepath Medical, Inc.

K number K180701

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GAP 2017-10-20

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

Applicant M/s. Meril Endo Surgery Private Limited.

K number K172149

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GAP 2016-11-23

SILK Surgical Suture

Applicant Teleflexmedical, Inc.

K number K162396

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GAP 2016-05-31

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

Applicant M/s. Meril Endo Surgery Private Limited.

K number K160623

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GAP 2008-06-09

WG-SURGICAL SUTURES WITH NEEDLE

Applicant Foosin Medical Supplies, Inc.

K number K080684

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GAP 2007-07-17

NON-ABSORBABLE SILK SUTURE

Applicant Arrow Intl., Inc.

K number K071111

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GAP 2006-05-19

MANI NEEDLE & SUTURE PACK (SILK)

Applicant Mani, Inc.

K number K053638

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GAP 2005-06-03

TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE

Applicant Sutures India Private Limited

K number K041514

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GAP 2004-12-01

UNISILK

Applicant United Medical Industries Co. , Ltd.

K number K042282

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GAP 2003-02-28

SILK SUTURES

Applicant Aurolab

K number K024091

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GAP 2002-11-25

DEMETECH SILK NONABSORBABLE SUTURE

Applicant Demetech Corp.

K number K023029

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GAP 2002-04-26

SERRALSILK

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

K number K020901

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GAP 2001-09-19

MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP

Applicant Johnson & Johnson Medical (China) , Ltd.

K number K012124

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GAP 2000-12-15

GRAMS SILK NONABSORBABLE SUTURE

Applicant Gramsmed, LLC

K number K003001

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GAP 2000-06-23

SILK, NONABSORBABLE, SURGICAL SUTURES, USP

Applicant Cp Medical

K number K001184

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GAP 2000-04-28

SILK NONABSORBABLE SURGICAL SUTURES, USP

Applicant Arc Medical Supplies (Beijing) Co, Ltd.

K number K000541

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GAP 2000-02-08

SUTRASILK SILK SUTURE

Applicant Visionary Medical Supplies, Inc.

K number K994177

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GAP 2000-02-04

SILK

Applicant Trading Consultants and Distributors Intl., Inc.

K number K993999

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GAP 1999-04-30

SILK SUTURE

Applicant Davis & Geck, Inc.

K number K982853

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GAP 1999-03-15

SILKAM NONABSORBABLE SILK SURGICAL SUTURE

Applicant Aesculap, Inc.

K number K990089

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GAP 1998-05-11

SOFSILK SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K981128

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GAP 1998-03-27

SOFSILK SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K980124

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GAP 1997-01-16

SOFSILK

Applicant United States Surgical, A Division of Tyco Healthc

K number K964581

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GAP 1996-03-04

SILK NONABSORBABLE SURGICAL SUTURES USP

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

K number K960328

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GAP 1994-12-05

SURGISILK

Applicant Sutures , Ltd.

K number K943627

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GAP 1994-07-26

SUTURES POLYPROP., POLYETHELINE, NYLON & SILK

Applicant Deknatel, Inc.

K number K930739

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GAP 1994-07-12

VISITEC PRECISE-POINT

Applicant Visitec Co.

K number K942234

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GAP 1994-03-03