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..

178
Total
178
Cleared
99d
Avg days
1977
Since
178 devices
97–120 of 178
Cleared Mar 20, 2003
GENICON CLIP APPLIER
K030269
Genicon, LC
General & Plastic Surgery · 52d
Cleared Feb 26, 2003
HEM-O-LOK XL CLIP
K030311
Weck
General & Plastic Surgery · 27d
Cleared Jan 17, 2003
COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K024366
Coalescent Surgical
General & Plastic Surgery · 17d
Cleared Oct 16, 2002
SANARUS INDICA MARKER SYSTEM
K020054
Sanarus Medical, Inc.
General & Plastic Surgery · 281d
Cleared Sep 25, 2002
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER)
K020879
Integrated Vascular Systems, Inc.
General & Plastic Surgery · 191d
Cleared Aug 14, 2002
WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
K021808
Weck
General & Plastic Surgery · 72d
Cleared Jul 03, 2002
COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES
K021407
Coalescent Surgical
General & Plastic Surgery · 61d
Cleared Mar 08, 2002
MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE
K020470
Bypass , Ltd.
General & Plastic Surgery · 24d
Cleared Nov 29, 2001
MICRO STAMPING LIGATING CLIP
K013264
Micro Stamping Corp.
General & Plastic Surgery · 59d
Cleared Sep 05, 2001
AMS SOFT-TISSUE APPROXIMATION SYSTEM
K012342
American Medical Systems, Inc.
General & Plastic Surgery · 43d
Cleared Aug 31, 2001
COALESCENT SURGICAL U-CLIP
K012317
Coalescent Surgical
General & Plastic Surgery · 39d
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
Cleared Mar 06, 2001
CARIS SITE MARKER
K003777
Artemis Medical, Inc.
General & Plastic Surgery · 89d
Cleared Feb 06, 2001
COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
K003958
Coalescent Surgical
General & Plastic Surgery · 47d
Cleared Dec 21, 2000
HEM-O-LOK SMX, MODEL 544220
K003337
Weck Closure Systems
General & Plastic Surgery · 57d
Cleared Jul 18, 2000
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 71d
Cleared Jun 23, 2000
VIVANT MEDICAL BIOPSY MARKER SYSTEM
K000278
Vivant Medical, Inc.
General & Plastic Surgery · 144d
Cleared Feb 04, 2000
COALESCENT SURGICAL SUTURED-CLIP
K994160
Coalescent Surgical
General & Plastic Surgery · 57d
Cleared Dec 23, 1999
THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP
K993424
Y-Clip Associates
General & Plastic Surgery · 72d
Cleared Dec 17, 1999
HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
K993157
Weck Closure Systems
General & Plastic Surgery · 87d
Cleared Dec 01, 1999
IMPLANTABLE CLIP FOR GENERAL SURGERY
K993135
Applied Medical Resources
General & Plastic Surgery · 72d
Cleared Jun 11, 1999
PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP
K991002
V. Mueller Neuro/Spine
General & Plastic Surgery · 78d
Cleared Jan 07, 1999
MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
K984438
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 24d