OCW · Class II · 21 CFR 876.1500

FDA Product Code OCW: Endoscopic Tissue Approximation Device

To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.

Leading manufacturers include Ethicon Endo-Surgery, Inc., Opus Medical, Inc. and Apollo Endosurgery, Inc..

71
Total
71
Cleared
118d
Avg days
1994
Since
71 devices
25–48 of 71
Cleared May 11, 2010
ACE STAPLER, MODEL F0031
K082044
Barosense, Inc.
Gastroenterology & Urology · 662d
Cleared Jul 22, 2009
ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
K091832
Endogastric Solutions, Inc.
Gastroenterology & Urology · 30d
Cleared May 14, 2009
AUTOSUTURE PROTACK
K090470
Covidien
General & Plastic Surgery · 80d
Cleared Mar 09, 2009
SILS STITCH ENDOSCOPIC SUTURING DEVICE
K090419
Covidien Lp, Formerly Registered AS United States
Gastroenterology & Urology · 19d
Cleared Sep 19, 2008
MODIFIED ENDO STICH
K082659
Covidien Lp, Formerly Registered AS United States
Gastroenterology & Urology · 7d
Cleared Aug 18, 2008
OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
K081853
Apollo Endosurgery, Inc.
General & Plastic Surgery · 49d
Cleared Jun 27, 2008
ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
K073644
Endogastric Solutions, Inc.
Gastroenterology & Urology · 184d
Cleared Mar 26, 2008
PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
K073671
Ndo Surgical, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 15, 2007
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER
K070151
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 211d
Cleared Apr 06, 2007
OPUS SMARTSTITCH SUTURE DEVICE
K070671
Arthrocare Corp.
Gastroenterology & Urology · 25d
Cleared Apr 05, 2007
MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM
K070352
Mini Lap Technologies, Inc.
Gastroenterology & Urology · 58d
Cleared Apr 05, 2007
MINI LAP INSTRUMENTS
K070686
Mini Lap Technologies, Inc.
Gastroenterology & Urology · 24d
Cleared Mar 09, 2007
ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
K062875
Endogastric Solutions, Inc.
Gastroenterology & Urology · 164d
Cleared Oct 02, 2006
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
K062244
Arthrocare Corp.
Gastroenterology & Urology · 60d
Cleared Sep 25, 2006
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
K061770
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 94d
Cleared Dec 30, 2003
SMARTSTITCH M-CONNECTOR, MODEL OM-8700
K033317
Opus Medical, Inc.
Gastroenterology & Urology · 76d
Cleared Dec 10, 2003
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 62d
Cleared Jul 28, 2003
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
K030170
Opus Medical, Inc.
Gastroenterology & Urology · 192d
Cleared Feb 14, 2003
SMARTSTITCH M-CONNECTOR, MODEL OM-8005
K023843
Opus Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 06, 2002
SMARTSTITCH SUTURE DEVICE, MODEL OM-8500
K022229
Opus Medical, Inc.
Gastroenterology & Urology · 58d
Cleared Jul 25, 2001
TACKER, MODEL R65-933
K003949
A & A Medical, Inc.
Gastroenterology & Urology · 216d
Cleared Feb 27, 2001
PARE ENDOSCOPIC SUTURING SYSTEM
K003102
Pare Surgical, Inc.
Gastroenterology & Urology · 146d
Cleared Nov 03, 2000
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
K002398
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 30, 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
K000717
Smith & Nephew, Inc.
Gastroenterology & Urology · 27d