Product Code: KGS FDA class 1 21 CFR 878.4930

Retention Device, Suture

General, Plastic Surgery

Suture Retention Device is a surgical accessory used to anchor or stabilize sutures at the wound site, preventing sutures from cutting through fragile tissue and distributing tension more evenly across the wound closure, particularly in patients with compromised tissue integrity. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGS, regulated under 21 CFR 878.4930, within the General, Plastic Surgery medical specialty.

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Basic Information

Product Code: KGS
Device Class: FDA class 1
Regulation Number: 878.4930
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K030031	SOFT TISSUE ANCHORING WASHERS	Jan 28, 2003	Substantially Equivalent	Accu-Speed, Incorporated
K020480	RBM	Mar 12, 2002	Substantially Equivalent	Smith & Nephew, Inc.
K964935	SUTURE LOCK	Feb 25, 1997	Substantially Equivalent	Smith & Nephew Endoscopy, Inc.
K941740	ACUFEX ROTATOR CUFF FIXATION BUTTON	Jun 30, 1995	Substantially Equivalent	Acufex Microsurgical, Inc.
K930675	MITEK CONE WASHER	Nov 09, 1993	Substantially Equivalent	Mitek Surgical Products, Inc.
K904435	VENTROFIL TENSION RELIEF SUTURE SET	Aug 29, 1991	Substantially Equivalent	Aesculap, Inc.
K911225	TRAY DOUGH	Apr 17, 1991	Substantially Equivalent	The Hygenic Corp.
K904136	SUTURE TENSION ADJUSTMENT REEL	Oct 02, 1990	Substantially Equivalent	Surgical Systems, Inc.
K902001	SURGICAL RETENTION BAR	May 09, 1990	Substantially Equivalent	Acufex Microsurgical, Inc.
K896310	ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE	Nov 20, 1989	Substantially Equivalent	Acufex Microsurgical, Inc.
K893995	DERMACARE TIE HOLDER	Aug 11, 1989	Substantially Equivalent	Dermacare
K884565	ACUFEX FIXATION BUTTON	Feb 27, 1989	Substantially Equivalent	Acufex Microsurgical, Inc.
K883299	SUTURE RETENTION DEVICE	Aug 23, 1988	Substantially Equivalent	Edwards Orthopaedics Div., Baxter Healthcare Corp.
K872608	HEWSON A.C.L. GUIDE SET	Sep 16, 1987	Substantially Equivalent	Concept, Inc.
K863570	LE VEEN WOUND SPLINT	Sep 29, 1986	Substantially Equivalent	Tek-Aid, Inc.
K832138	BIOMER * PLEDGET SUTURE BUTTRESS	May 23, 1984	Substantially Equivalent	ETHICON, Inc.
K813581	CRUCIATE LIGAMENT BUTTON	Mar 23, 1982	Substantially Equivalent	Biomet, Inc.
K812819	ETHICON* SURGICAL SUTURES W/COMPRESS BOL	Nov 20, 1981	Substantially Equivalent	ETHICON, Inc.
K792004	HEWSON LIGAMENT BUTTON	Nov 05, 1979	Substantially Equivalent	Richard'S Medical Equip., Inc.
K771554	SUTURE RETENTION CLAMP	Sep 02, 1977	Substantially Equivalent	Concept, Inc.