FDA.reportPublic FDA data

510(k) K213271

Device
MedicloseTM System
Applicant
Health Value Creation B.V., Trading AS Corporis Medical
510(k) number
K213271
Product code
OCW
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-31
Date received
2021-09-30
Regulation
876.1500
Classification name
Endoscopic Tissue Approximation Device
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kim Sondeijker
Address
Oxfordlaan 55 Maastricht NL 6229 EV 6229 EV

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OCW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.2026-02-13
K243750SimpleStitch Suturing SystemEnvision Endoscopy2025-04-17
K231240MaxTack™ Motorized Fixation DeviceCovidien2023-09-08
K231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.2023-06-29
K211309endomina systemEndo Tools Therapeutics S.A.2021-12-07
K201744Su2ura Approximation DeviceAnchora Medical, Ltd.2021-06-17
K210266OverStitch Sx Endoscopic Suturing SystemApollo Endosurgery, Inc.2021-03-02
K193652AbClose - Port Site Closure DeviceMedeon Biodesign, Inc.2020-03-26
K191439OverStitch 2-0 Polypropylene SutureApollo Endosurgery2019-08-29
K181141OverStitch Endoscopic Suturing System and AccessoriesApollo Endosurgery2018-06-27
K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc.2018-02-12
K172666CrossBow Fascial Closure System, CrossBow Fascial Closure System with AdaptorSutureease, Inc.2017-12-01
K171886OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc.2017-11-15
K160117AbClose - Port Site Closure DeviceMedeon Biodesign, Inc.2016-09-09
K160149Miret Grasper, Alligator, Miret Grasper, MarylandMiret Surgical, Inc.2016-08-30