Product Code: GAP FDA class 2 21 CFR 878.5030

Suture, Nonabsorbable, Silk

General, Plastic Surgery

The Suture, Nonabsorbable, Silk (product code GAP) is a nonabsorbable suture made from natural silk fibers, used for wound closure and tissue approximation in general and plastic surgery procedures. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The device is regulated under 21 CFR 878.5030 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as silk sutures are embedded within tissue during use.

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510(k)s

FEI Numbers

120

Registration Numbers

120

Unique Applicants

Years Active

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Basic Information

Product Code: GAP
Device Class: FDA class 2
Regulation Number: 878.5030
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 41 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241486	Sofsilk Coated Braided Silk Suture	Dec 03, 2024	Substantially Equivalent	Covidien
K222944	SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture	Oct 18, 2024	Substantially Equivalent	Safepath Medical, Inc.
K232355	Non absorbable Surgical Silk Suture	Jan 16, 2024	Substantially Equivalent	Shandong Haidike Medical Product Co., Ltd.
K221767	Surgical Sutures with or without Needle	Jul 31, 2023	Substantially Equivalent	Huaian Seamen Medical Technology Co., Ltd.
K180701	SafePath Suturing System	Jun 25, 2018	Substantially Equivalent	Safepath Medical, Inc.
K172149	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	Oct 20, 2017	Substantially Equivalent	M/s. Meril Endo Surgery Private Limited.
K162396	SILK Surgical Suture	Nov 23, 2016	Substantially Equivalent	Teleflexmedical, Inc.
K160623	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	May 31, 2016	Substantially Equivalent	M/s. Meril Endo Surgery Private Limited.
K080684	WG-SURGICAL SUTURES WITH NEEDLE	Jun 09, 2008	Substantially Equivalent	Foosin Medical Supplies, Inc.
K071111	NON-ABSORBABLE SILK SUTURE	Jul 17, 2007	Substantially Equivalent	Arrow Intl., Inc.
K053638	MANI NEEDLE & SUTURE PACK (SILK)	May 19, 2006	Substantially Equivalent	Mani, Inc.
K041514	TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE	Jun 03, 2005	Substantially Equivalent	Sutures India Private Limited
K042282	UNISILK	Dec 01, 2004	Substantially Equivalent	United Medical Industries Co. , Ltd.
K024091	SILK SUTURES	Feb 28, 2003	Substantially Equivalent	Aurolab
K023029	DEMETECH SILK NONABSORBABLE SUTURE	Nov 25, 2002	Substantially Equivalent	Demetech Corp.
K020901	SERRALSILK	Apr 26, 2002	Substantially Equivalent	Serral, S.A. DE C.V.
K012124	MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP	Sep 19, 2001	Substantially Equivalent	Johnson & Johnson Medical (China) , Ltd.
K003001	GRAMS SILK NONABSORBABLE SUTURE	Dec 15, 2000	Substantially Equivalent	Gramsmed, LLC
K001184	SILK, NONABSORBABLE, SURGICAL SUTURES, USP	Jun 23, 2000	Substantially Equivalent for Some Indications	Cp Medical
K000541	SILK NONABSORBABLE SURGICAL SUTURES, USP	Apr 28, 2000	Substantially Equivalent	Arc Medical Supplies (Beijing) Co, Ltd.
K994177	SUTRASILK SILK SUTURE	Feb 08, 2000	Substantially Equivalent	Visionary Medical Supplies, Inc.
K993999	SILK	Feb 04, 2000	Substantially Equivalent	Trading Consultants and Distributors Intl., Inc.
K982853	SILK SUTURE	Apr 30, 1999	Substantially Equivalent for Some Indications	Davis & Geck, Inc.
K990089	SILKAM NONABSORBABLE SILK SURGICAL SUTURE	Mar 15, 1999	Substantially Equivalent	Aesculap, Inc.
K981128	SOFSILK SUTURE	May 11, 1998	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K980124	SOFSILK SUTURE	Mar 27, 1998	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K964581	SOFSILK	Jan 16, 1997	Substantially Equivalent for Some Indications	United States Surgical, A Division of Tyco Healthc
K960328	SILK NONABSORBABLE SURGICAL SUTURES USP	Mar 04, 1996	Substantially Equivalent for Some Indications	R. K. Medical L. L. C.
K943627	SURGISILK	Dec 05, 1994	Substantially Equivalent for Some Indications	Sutures , Ltd.
K930739	SUTURES POLYPROP., POLYETHELINE, NYLON & SILK	Jul 26, 1994	Substantially Equivalent	Deknatel, Inc.
K942234	VISITEC PRECISE-POINT	Jul 12, 1994	Substantially Equivalent	Visitec Co.
K931913	SUTURE NON-ABSORBABLE SILK	Mar 03, 1994	Substantially Equivalent	Surgimetrics International, Ltd.
K930826	SUTURE NONABSORBABLE - SILK	Jan 07, 1994	Substantially Equivalent	Surgical Specialties, Inc.
K930825	SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES	Jan 07, 1994	Substantially Equivalent	Surgical Specialties, Inc.
K905454	ADVANCE SUTURE NONABSORBABLE SILK SUTURE	Jun 28, 1991	Substantially Equivalent	Advance Suture, Inc.
K905287	IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES	Feb 11, 1991	Substantially Equivalent	Internacional Farmaceutica, S.A. DE C.V.
K904891	NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE)	Nov 14, 1990	Substantially Equivalent for Some Indications	United States Surgical, A Division of Tyco Healthc
K904478	NONABSORBABLE SILK SURGICAL SUTURE	Nov 14, 1990	Substantially Equivalent for Some Indications	United States Surgical, A Division of Tyco Healthc
K761199	AIRWAY PRESSURE MONITOR	Feb 28, 1977	Substantially Equivalent	Draeger Medical, Inc.
K760650	RETRACTOR, GERBODE STERNAL	Sep 21, 1976	Substantially Equivalent	Dilling Co.
K760158	NEEDLES AND SUTURES, SILK & NYLON	Aug 19, 1976	Substantially Equivalent	Alcon Laboratories