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., United States Surgical, A Division of Tyco Healthc and Covidien.

70
Total
70
Cleared
118d
Avg days
1994
Since
70 devices
25–48 of 70
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
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