FDA Product Code GAP: Suture, Nonabsorbable, Silk
Leading manufacturers include Huaian Seamen Medical Technology Co., Ltd., Safepath Medical, Inc. and Shandong Haidike Medical Product Co., Ltd..
FDA 510(k) Cleared Suture, Nonabsorbable, Silk Devices (Product Code GAP)
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 Review Time
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 →