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., Apollo Endosurgery, Inc. and United States Surgical, A Division of Tyco Healthc.

70
Total
70
Cleared
118d
Avg days
1994
Since
70 devices
25–48 of 70
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 10, 2003
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 62d
Cleared Jul 25, 2001
TACKER, MODEL R65-933
K003949
A & A Medical, Inc.
Gastroenterology & Urology · 216d
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
Cleared Mar 01, 2000
SUPERSTITCH
K994087
Sutura, Inc.
Gastroenterology & Urology · 89d
Cleared Jul 14, 1999
SMITH & NEPHEW SUTURE LOK
K991500
Smith & Nephew Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared May 01, 1998
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
K980815
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 59d
Cleared Jan 30, 1998
UROMED NEEDLE GRASPER
K974137
Uromed Corp.
Gastroenterology & Urology · 88d
Cleared Dec 01, 1997
INNOVASIVE DEVICES Y-KNOT SUTURE CLIP
K973313
Innovasive Devices, Inc.
Gastroenterology & Urology · 89d
Cleared Aug 06, 1997
SMITH & NEPHEW SUTURE COLLET
K971939
Smith & Nephew Endoscopy, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 27, 1997
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER
K970720
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 120d
Cleared Nov 27, 1996
AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
K963999
United States Surgical, A Division of Tyco Healthc
Gastroenterology & Urology · 51d
Cleared Sep 11, 1996
ENDOSCOPIC CLIP APPLIER
K962493
Aesculap, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 25, 1996
ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
K961390
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 21, 1996
ENDOSCOPIC NEEDLE DRIVER
K960011
United States Surgical, A Division of Tyco Healthc
Gastroenterology & Urology · 50d
Cleared Dec 08, 1995
KOH MICRO-SUTURING INSTRUMENTS
K955479
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 8d
Cleared Jan 19, 1995
ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADING UNIT
K945202
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 86d
Cleared Nov 28, 1994
ORIGIN TACKER SYSTEM
K944415
Origin Medsystems, Inc.
Gastroenterology & Urology · 81d
Cleared Nov 15, 1994
DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER
K944435
Deroyal Industries, Inc.
Gastroenterology & Urology · 64d
Cleared May 27, 1994
MODIFIED ENDOPATH ILS
K940967
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 86d
Cleared Apr 21, 1994
ENDOSCOPIC ARTICULATING MULTI-FEED STAPLER WITH RELOAD UNIT
K935756
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 146d
Cleared Mar 16, 1994
AUTOSUTURE ENDOSCOPIC SUTURING DEVICE
K934738
United States Surgical, A Division of Tyco Healthc
Gastroenterology & Urology · 166d