OCW

Endoscopic Tissue Approximation Device

Product code
OCW
Device name
Endoscopic Tissue Approximation Device
Device class
Class 2
21 CFR
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
70 (all years; only the last 3 years are listed here)

FDA classification definition

To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-02-13.

NumberDecision dateApplicantDevice nameSummary
K2524002026-02-13Endo Tools Therapeutics S.A.Endomina EZFuse systemPDF
K2437502025-04-17Envision EndoscopySimpleStitch Suturing SystemPDF

2 summaries are archived here for direct download.

Official FDA classification page: OCW
Classification and pathway per current FDA publications. Data from openFDA (CC0).