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
177 devices
73–96 of 177
Cleared Jul 18, 2000
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 71d
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
Cleared Nov 19, 1998
HEM-O-LOK MODEL NUMBERS 523900, 523970
K982941
Weck Closure Systems
General & Plastic Surgery · 90d
Cleared Nov 19, 1998
HEM-O-LOCK, MODEL 523935
K982944
Weck Closure Systems
General & Plastic Surgery · 90d
Cleared Oct 13, 1998
TITANIUM HEMOSTATIC CLIP
K981645
Vitalitec Int'L., Inc.
General & Plastic Surgery · 158d
Cleared Aug 10, 1998
HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS
K982313
Weck Closure Systems
General & Plastic Surgery · 40d
Cleared Jul 28, 1998
INFLUENCE CLIP SYSTEM
K981631
Influence, Inc.
General & Plastic Surgery · 82d
Cleared May 14, 1998
DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
K981239
Deroyal Surgical
General & Plastic Surgery · 41d
Cleared Mar 27, 1998
DUOCLIPPER TITANIUM CLIPS
K973652
Scion International, Inc.
General & Plastic Surgery · 183d
Cleared Oct 24, 1997
EVI SUTURED-CLIP APPLIER
K971588
Elective Vascular Intervention Inc. (Evi)
General & Plastic Surgery · 176d
Cleared Jul 30, 1997
IMPLANTABLE CLIP
K970793
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 148d
Cleared Jun 03, 1997
AUTO SUTURE* ILM** KIT
K971201
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 63d
Cleared Jan 22, 1997
APPLIED MEDICAL CLIP APPLIER
K964470
Applied Medical Resources
General & Plastic Surgery · 76d
Cleared Nov 27, 1996
MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP
K964109
Microsurge, Inc.
General & Plastic Surgery · 43d
Cleared Sep 23, 1996
AUTO SUTURE MODIFIED VCS CLIP APPLIER
K962043
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 118d
Cleared Jul 24, 1996
MEDLINE TITANIUM HEMOCLIPS
K962016
Medline Industries, Inc.
General & Plastic Surgery · 62d
Cleared Jan 05, 1996
TITANIUM HEMOSTATIC CLIP
K953258
Intramed Laboratories, Inc.
General & Plastic Surgery · 177d
Cleared Nov 30, 1995
DAVIS & GECK LIGATING CLIP REMOVER
K953908
Davis & Geck, Inc.
General & Plastic Surgery · 101d
Cleared Apr 13, 1995
IMPLANTABLE CLIP
K950540
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 65d