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Data / Medical devices / Endoscopic Tissue Approximation Device / United States

FDA-registered makers of Endoscopic Tissue Approximation Device in the United States: 18 establishments

18 establishments in the United States are registered with the FDA to make Endoscopic Tissue Approximation Device (product code OCW). 12 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Endoscopic Tissue Approximation Device
Product code
OCW
Country
United States

Makers of Endoscopic Tissue Approximation Device in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer7February 12, 2018000api.fda.gov
CovidienNorth Haven, CT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer5September 8, 2023020api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer4June 29, 2023010api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer3June 29, 2023000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler3October 8, 2013000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer2May 14, 2009000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer2April 5, 2007000api.fda.gov
CovidienPonce, PR, United StatesManufacturer1May 14, 2009000api.fda.gov
Envision Endoscopy Inc.Waltham, MA, United StatesComplaint file establishment, Manufacturer, Specification developer1April 17, 2025000api.fda.gov
Ethicon Endo-Surgery, Inc.Cincinnati, OH, United StatesSpecification developer1May 27, 1994000api.fda.gov
Ethicon Endo-Surgery, LLCGuaynabo, PR, United StatesSpecification developer1May 27, 1994000api.fda.gov
Suture Ease, Inc.Galt, CA, United StatesComplaint file establishment, Specification developer1December 1, 2017000api.fda.gov
Atc Technologies Inc.Wilmington, MA, United StatesContract manufacturer0000api.fda.gov
Endofix Medical TechnologiesPlainville, MA, United StatesSpecification developer0000api.fda.gov
Grace Manufacturing IncRussellville, AR, United StatesContract manufacturer0000api.fda.gov
Lacey Manufacturing Company LLCBridgeport, CT, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Sage Product Development, Inc.Foxborough, MA, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.