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FDA 510(k)

Mediclose Cartridge System

K-Number: K262044 · 2026-10-14

ApplicantHealth Value Creation B.V. (trading as Corporis Medical)
Decision Date2026-10-14
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Mediclose Cartridge System is the device name listed in this FDA 510(k) record. The listed applicant is Health Value Creation B.V. (trading as Corporis Medical). It received FDA 510(k) clearance on 2026-10-14 under 510(k) number K262044. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mediclose Cartridge System?

Mediclose Cartridge System is a medical device that received FDA 510(k) clearance on 2026-10-14. The listed applicant is Health Value Creation B.V. (trading as Corporis Medical). The 510(k) number is K262044.

When did Mediclose Cartridge System receive FDA 510(k) clearance?

Mediclose Cartridge System received FDA 510(k) clearance on 2026-10-14, under 510(k) number K262044.

Who is the listed applicant for Mediclose Cartridge System?

The FDA 510(k) record lists Health Value Creation B.V. (trading as Corporis Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mediclose Cartridge System?

The FDA product code for Mediclose Cartridge System is OCW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Health Value Creation B.V. (trading as Corporis Medical) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213271MedicloseTM System

Related Devices (Code: OCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.K243750SimpleStitch Suturing SystemEnvision EndoscopyK231240MaxTack™ Motorized Fixation DeviceCovidienK213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.K211309endomina systemEndo Tools Therapeutics S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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