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
49–72 of 177
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 Apr 23, 2010
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
K091987
LeMaitre Vascular, Inc.
General & Plastic Surgery · 295d
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 Dec 19, 2006
U-CLIP DEVICE
K062821
Medtronic Neurosurgery
General & Plastic Surgery · 90d
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
Cleared Aug 02, 2006
U-CLIP DEVICE, MODEL NC65
K062057
Medtronic Vascular
General & Plastic Surgery · 13d
Cleared Dec 16, 2005
U-CLIP DEVICE, MODELS B140, B160 AND B180
K053252
Medtronic Vascular
General & Plastic Surgery · 25d
Cleared Nov 04, 2005
MILTEX LIGATING CLIP
K052018
Miltex, Inc.
General & Plastic Surgery · 101d
Cleared Jun 08, 2005
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
K051125
Abbott Laboratories
General & Plastic Surgery · 36d
Cleared May 05, 2005
COMPRESSION ANASTOMOSIS RING (CAR)
K050356
Niti Medical Technologies , Ltd.
General & Plastic Surgery · 80d
Cleared Mar 14, 2005
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER
K050344
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 31d
Cleared Dec 01, 2004
LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
K043115
Niti Medical Technologies , Ltd.
General & Plastic Surgery · 21d
Cleared Sep 16, 2004
COMPRESSION ANASTOMOSIS CLIP (CAC)
K041751
Niti Medical Technologies , Ltd.
General & Plastic Surgery · 79d
Cleared Dec 18, 2003
AMI REPROCESSED MULTIPLE CLIP APPLIERS
K032980
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 85d
Cleared Oct 24, 2003
MODIFICATION TO SUTURE CLINCH
K033024
Applied Medical Resources Corp.
General & Plastic Surgery · 28d
Cleared Jul 21, 2003
FAST THROW STAINLESS STEEL SURGICAL SUTURE
K030926
Advanced Surgical Products, Inc.
General & Plastic Surgery · 119d
Cleared Sep 05, 2001
AMS SOFT-TISSUE APPROXIMATION SYSTEM
K012342
American Medical Systems, Inc.
General & Plastic Surgery · 43d
Cleared Jul 16, 2001
BIOPSY SITE MARKER
K011402
Senorx, Inc.
General & Plastic Surgery · 70d
Cleared May 14, 2001
MODIFICATION TO IMPLANTABLE CLIP
K011236
Applied Medical Resources Corp.
General & Plastic Surgery · 21d