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, Safepath Medical, Inc. and Huaian Seamen Medical Technology Co., Ltd..

41
Total
41
Cleared
147d
Avg days
1976
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 473d recently vs 130d 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 Mar 15, 1999
SILKAM NONABSORBABLE SILK SURGICAL SUTURE
K990089
Aesculap, Inc.
General & Plastic Surgery · 63d
Cleared May 11, 1998
SOFSILK SUTURE
K981128
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 42d
Cleared Mar 27, 1998
SOFSILK SUTURE
K980124
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 72d
Cleared Jan 16, 1997
SOFSILK
K964581
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 62d
Cleared Nov 14, 1990
NONABSORBABLE SILK SURGICAL SUTURE
K904478
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 47d
Cleared Nov 14, 1990
NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE)
K904891
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 15d

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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - GAP Product Code

Recent submissions under GAP have taken an average of 473 days to reach a decision - up from 130 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 →