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OCW — Endoscopic Tissue Approximation Device Class II

FDA Device Classification

Classification Details

Product Code
OCW
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252400endo tools therapeuticsEndomina EZFuse systemFebruary 13, 2026
K243750envision endoscopySimpleStitch Suturing SystemApril 17, 2025
K231240covidienMaxTack™ Motorized Fixation DeviceSeptember 8, 2023
K213271health value creation b.v., trading as corporis medicalMedicloseTM SystemAugust 31, 2023
K231553apollo endosurgeryOverStitch NXT Endoscopic Suturing SystemJune 29, 2023
K211309endo tools therapeuticsendomina systemDecember 7, 2021
K201744anchora medicalSu2ura Approximation DeviceJune 17, 2021
K210266apollo endosurgeryOverStitch Sx Endoscopic Suturing SystemMarch 2, 2021
K193652medeon biodesignAbClose - Port Site Closure DeviceMarch 26, 2020
K191439apollo endosurgeryOverStitch 2-0 Polypropylene SutureAugust 29, 2019
K181141apollo endosurgeryOverStitch Endoscopic Suturing System and AccessoriesJune 27, 2018
K172775teleflexmedicalMiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleFebruary 12, 2018
K172666sutureeaseCrossBow Fascial Closure System, CrossBow Fascial Closure System with AdaptorDecember 1, 2017
K171886apollo endosurgeryOverStitch SX Endoscopic Suturing System (ESS)November 15, 2017
K160117medeon biodesignAbClose - Port Site Closure DeviceSeptember 9, 2016
K160149miret surgicalMiret Grasper, Alligator, Miret Grasper, MarylandAugust 30, 2016
K132232minilap technologiesMINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEMDecember 4, 2013
K132362teleflexmedicalWECK EFX ENDO FASCIAL CLOSURE SYSTEMOctober 8, 2013
K120147barosenseACE STAPLER AND CARTRIDGEFebruary 17, 2012
K110829barosenseACE STAPLER AND CARTRIDGEJune 3, 2011