FDA Product Code FZP: Clip, Implantable
Under FDA product code FZP, implantable clips are cleared for soft tissue approximation, ligation, and fixation during surgical procedures.
These metal or polymer clips are used to occlude blood vessels, close tissue defects, and mark anatomical landmarks during open and minimally invasive surgery. They are used in vascular ligation, lymph node marking, and laparoscopic cholecystectomy.
FZP devices are Class II medical devices, regulated under 21 CFR 878.4300 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Teleflex Medical, Taiwan Surgical Corporation and Medscope Biotech Co., Ltd..
FDA 510(k) Cleared Clip, Implantable Devices (Product Code FZP)
About Product Code FZP - Regulatory Context
510(k) Submission Activity
176 total 510(k) submissions under product code FZP since 1977, with 176 receiving FDA clearance (average review time: 97 days).
Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.
FDA Review Time
Recent submissions under FZP have taken an average of 221 days to reach a decision - up from 93 days historically. Manufacturers should account for longer review timelines in current project planning.
FZP devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →