FZP · Class II · 21 CFR 878.4300

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 United States Surgical, A Division of Tyco Healthc, Ethicon, Inc. and AtriCure, Inc..

177
Total
177
Cleared
98d
Avg days
1977
Since
Stable submission activity - 6 submissions in the last 2 years
Review times increasing: avg 123d recently vs 97d historically

FDA 510(k) Cleared Clip, Implantable Devices (Product Code FZP)

177 devices
1–24 of 177
Cleared Dec 22, 2025
InnoClip Clip Applier
K253781
Taiwan Surgical Corporation
General & Plastic Surgery · 26d
Cleared Dec 22, 2025
InnoClip Disposable Clip Applier
K253903
Taiwan Surgical Corporation
General & Plastic Surgery · 17d
Cleared Nov 20, 2025
Disposable Polymer Ligation Clips
K250643
Hangzhou Kangji Medical Instrument Co., Ltd.
General & Plastic Surgery · 261d
Cleared Jul 03, 2025
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
K251054
Teleflex Medical
General & Plastic Surgery · 90d
Cleared Jan 15, 2025
GEM ZIPCLIP
K242541
Synovis Micro Companies Alliance A Subsidiary of Baxter Int
General & Plastic Surgery · 142d
Cleared Jul 18, 2024
SOLID CLIP™ Single Use Clip Applier
K221495
Medscope Biotech Co., Ltd.
General & Plastic Surgery · 787d
Cleared Jan 12, 2024
Hem-o-lok® Ligating Clips
K232970
Teleflex Medical
General & Plastic Surgery · 113d
Cleared Sep 19, 2023
angiOCCLUDE Ligating Clips
K230966
A2 Medical Systems, LLC
General & Plastic Surgery · 167d
Cleared Aug 29, 2023
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420)
K232313
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 27d
Cleared Apr 28, 2023
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
K230480
Teleflex Medical
General & Plastic Surgery · 65d
Cleared Jul 22, 2022
DuraFuse Clip and Applier System
K213813
Neuramedica, Inc.
General & Plastic Surgery · 227d
Cleared Mar 02, 2022
angioLOCK Polymer Ligating Clip
K220006
A2 Medical Systems, LLC
General & Plastic Surgery · 57d
Cleared Jan 04, 2022
InnoClip Disposable Clip Applier, InnoClip Clip Applier
K202994
Taiwan Surgical Corporation
General & Plastic Surgery · 460d
Cleared Nov 23, 2020
Mirus Ligating Clip, Mirus Ligating Clip Applier
K200166
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 306d
Cleared Sep 02, 2020
Aesculap PAS-Port Proximal Anastomosis System
K202124
Aesculap, Inc.
General & Plastic Surgery · 33d
Cleared Dec 20, 2019
Dannik Titanium Ligation Clip
K192711
Dannik
General & Plastic Surgery · 84d
Cleared Nov 15, 2018
Amsel Endo Occluder
K180650
Amsel Medical Corporation
General & Plastic Surgery · 247d
Cleared Oct 30, 2018
LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier
K181488
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 146d
Cleared Mar 08, 2018
AnastoClip GC Closure System
K173323
LeMaitre Vascular, Inc.
General & Plastic Surgery · 139d
Cleared Jan 31, 2018
AtriClip FLEX-V
K180010
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Oct 25, 2017
AtriClip LAA Exclusion System with Preloaded PRO·V Clip
K173031
AtriCure, Inc.
General & Plastic Surgery · 27d
Cleared Oct 11, 2017
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
K172742
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared May 19, 2017
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
K163261
AtriCure, Inc.
General & Plastic Surgery · 179d
Cleared Sep 07, 2016
Weck Auto Endo10 Automatic Endoscopic Clip Applier
K161758
Teleflex Medical
General & Plastic Surgery · 72d

About Product Code FZP - Regulatory Context

510(k) Submission Activity

177 total 510(k) submissions under product code FZP since 1977, with 177 receiving FDA clearance (average review time: 98 days).

Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.

FDA 510(k) Review Time - FZP Product Code

Recent submissions under FZP have taken an average of 123 days to reach a decision - up from 97 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 →