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 Opus Medical, Inc..

71
Total
71
Cleared
118d
Avg days
1994
Since
71 devices
49–71 of 71
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 28, 1995
ENDO-LEADER
K954641
Microsurge, Inc.
General & Plastic Surgery · 79d
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
SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE
K944292
Surgical Innovations Corp.
Gastroenterology & Urology · 74d
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
Cleared Mar 09, 1994
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
K934174
Ethicon, Inc.
General & Plastic Surgery · 194d
Cleared Feb 07, 1994
PROXIMATE ARTICULATING LINEAR STAPLER
K932434
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 263d
Cleared Jan 03, 1994
ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION
K935064
Ethicon, Inc.
Gastroenterology & Urology · 75d