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, AtriCure, Inc. and Ethicon, Inc..

177
Total
177
Cleared
98d
Avg days
1977
Since
177 devices
25–48 of 177
Cleared Mar 18, 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K160454
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Jan 27, 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
K153500
AtriCure, Inc.
General & Plastic Surgery · 51d
Cleared Oct 23, 2015
SureClip
K150936
Conmed Corporation
General & Plastic Surgery · 199d
Cleared Sep 14, 2015
Premium Surgiclip¿
K143644
Covidien
General & Plastic Surgery · 266d
Cleared Sep 10, 2015
Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier
K150840
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 164d
Cleared Aug 26, 2015
Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
K152081
Teleflexmedical, Inc.
General & Plastic Surgery · 30d
Cleared Jun 17, 2015
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K150996
AtriCure, Inc.
General & Plastic Surgery · 63d
Cleared Mar 12, 2015
Lapro-Clip Auto Suture Reusable Long Clip Applier
K143598
Covidien, LLC
General & Plastic Surgery · 84d
Cleared Dec 19, 2014
Weck Hem-o-lok Auto Endo5 Ligating Clip Applier
K142777
Teleflexmedical, Inc.
General & Plastic Surgery · 84d
Cleared Oct 30, 2014
Premium Surgiclip III
K142869
Covidien
General & Plastic Surgery · 29d
Cleared Aug 28, 2014
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
K142120
AtriCure, Inc.
General & Plastic Surgery · 24d
Cleared Dec 03, 2013
HEM-O-LOK LIGATING CLIP
K133202
Teleflex Medical
General & Plastic Surgery · 47d
Cleared Nov 27, 2013
HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
K132658
Teleflex Medical
General & Plastic Surgery · 93d
Cleared May 14, 2013
ATRICLIP GILLINOV-COSGROVE LAA CLIP
K131107
AtriCure, Inc.
General & Plastic Surgery · 25d
Cleared Aug 29, 2012
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
K122276
AtriCure, Inc.
General & Plastic Surgery · 30d
Cleared May 03, 2012
ENDO CLIP III 5MM CLIP APPLIER
K121194
Covidien
General & Plastic Surgery · 14d
Cleared Aug 06, 2010
ENDOSCOPIC CLIP SYSTEM
K102081
Aesculap, Inc.
General & Plastic Surgery · 11d
Cleared Jun 10, 2010
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
K093679
AtriCure, Inc.
General & Plastic Surgery · 195d
Cleared May 07, 2008
U-CLIP UNI-FIRE, MODEL M65
K081082
Medtronic, Inc.
General & Plastic Surgery · 21d
Cleared May 05, 2008
ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE
K081031
Aesculap, Inc.
General & Plastic Surgery · 24d
Cleared Apr 02, 2008
AESCULAP ENDOSCOPIC CLIP SYTEM
K080753
Aesculap, Inc.
General & Plastic Surgery · 16d
Cleared Nov 21, 2007
AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
K071406
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 184d
Cleared Nov 02, 2006
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
K061288
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 177d
Cleared Nov 02, 2006
HEM-O-LOK LIGATION CLIP
K062914
Teleflex Medical
General & Plastic Surgery · 36d