GAP · Class II · 21 CFR 878.5030

FDA Product Code GAP: Suture, Nonabsorbable, Silk

Leading manufacturers include United States Surgical, A Division of Tyco Healthc, Surgical Specialties, Inc. and M/s. Meril Endo Surgery Private Limited..

41
Total
41
Cleared
147d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 193d recently vs 145d historically

FDA 510(k) Cleared Suture, Nonabsorbable, Silk Devices (Product Code GAP)

41 devices
1–24 of 41
Cleared Dec 03, 2024
Sofsilk™ Coated Braided Silk Suture
K241486
Covidien
General & Plastic Surgery · 193d
Cleared Oct 18, 2024
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
K222944
Safepath Medical, Inc.
General & Plastic Surgery · 753d
Cleared Jan 16, 2024
Non absorbable Surgical Silk Suture
K232355
Shandong Haidike Medical Product Co., Ltd.
General & Plastic Surgery · 162d
Cleared Jul 31, 2023
Surgical Sutures with or without Needle
K221767
Huaian Seamen Medical Technology Co., Ltd.
General & Plastic Surgery · 409d
Cleared Jun 25, 2018
SafePath Suturing System
K180701
Safepath Medical, Inc.
General & Plastic Surgery · 101d
Cleared Oct 20, 2017
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
K172149
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 95d
Cleared Nov 23, 2016
SILK Surgical Suture
K162396
Teleflexmedical, Inc.
General & Plastic Surgery · 89d
Cleared May 31, 2016
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
K160623
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 88d
Cleared Jun 09, 2008
WG-SURGICAL SUTURES WITH NEEDLE
K080684
Foosin Medical Supplies, Inc.
General & Plastic Surgery · 91d
Cleared Jul 17, 2007
NON-ABSORBABLE SILK SUTURE
K071111
Arrow Intl., Inc.
General & Plastic Surgery · 88d
Cleared May 19, 2006
MANI NEEDLE & SUTURE PACK (SILK)
K053638
Mani, Inc.
General & Plastic Surgery · 141d
Cleared Jun 03, 2005
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
K041514
Sutures India Private Limited
General & Plastic Surgery · 361d
Cleared Dec 01, 2004
UNISILK
K042282
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 99d
Cleared Feb 28, 2003
SILK SUTURES
K024091
Aurolab
General & Plastic Surgery · 79d
Cleared Nov 25, 2002
DEMETECH SILK NONABSORBABLE SUTURE
K023029
Demetech Corp.
General & Plastic Surgery · 75d
Cleared Apr 26, 2002
SERRALSILK
K020901
Serral, S.A. DE C.V.
General & Plastic Surgery · 37d
Cleared Sep 19, 2001
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
K012124
Johnson & Johnson Medical (China) , Ltd.
General & Plastic Surgery · 75d
Cleared Dec 15, 2000
GRAMS SILK NONABSORBABLE SUTURE
K003001
Gramsmed, LLC
General & Plastic Surgery · 80d
Cleared Jun 23, 2000
SILK, NONABSORBABLE, SURGICAL SUTURES, USP
K001184
Cp Medical
General & Plastic Surgery · 73d
Cleared Apr 28, 2000
SILK NONABSORBABLE SURGICAL SUTURES, USP
K000541
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 71d
Cleared Feb 08, 2000
SUTRASILK SILK SUTURE
K994177
Visionary Medical Supplies, Inc.
General & Plastic Surgery · 60d
Cleared Feb 04, 2000
SILK
K993999
Trading Consultants and Distributors Intl., Inc.
General & Plastic Surgery · 72d
Cleared Apr 30, 1999
SILK SUTURE
K982853
Davis & Geck, Inc.
General & Plastic Surgery · 260d
Cleared Mar 15, 1999
SILKAM NONABSORBABLE SILK SURGICAL SUTURE
K990089
Aesculap, Inc.
General & Plastic Surgery · 63d

About Product Code GAP - Regulatory Context

510(k) Submission Activity

41 total 510(k) submissions under product code GAP since 1976, with 41 receiving FDA clearance (average review time: 147 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - GAP Product Code

Recent submissions under GAP have taken an average of 193 days to reach a decision - up from 145 days historically. Manufacturers should account for longer review timelines in current project planning.

GAP devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →