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Panels › Gastroenterology, Urology › Product code OCW · Class 2

Endoscopic Tissue Approximation Device

Regulation 876.1500

2510(k)s in 12 months (71 all time)
3recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in OCW

Company510(k)sRecalls
Ethicon Endo-Surgery, Inc.110
Apollo Endosurgery60
Covidien22
Opus Medical, Inc.40
Barosense, Inc.30
Endogastric Solutions, Inc.30
Mini Lap Technologies, Inc.30
United States Surgical, A Division of Tyco Healthc30
Arthrocare Corp.20
Boston Scientific Corporation02
DateFirm and productCodeLinked 510(k)
Aug 14, 2026Boston Scientific Corporation
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Open, Classified		 OCWK181141
K201808
Aug 14, 2026Boston Scientific Corporation
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Open, Classified		 OCWK181141
K201808
Jun 1, 2026Covidien, LP
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Open, Classified		 OCWK934738
Feb 6, 2024Covidien LP
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Mo
Open, Classified		 OCWK090470

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