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FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Tracker / October 2026 / K262044

510(k) cleared

Mediclose Cartridge System

Health Value Creation B.V. (trading as Corporis Medical) · Oct 14, 2026 · K262044

FDA cleared the Mediclose Cartridge System from Health Value Creation B.V. (trading as Corporis Medical) on Oct 14, 2026 under K262044, a traditional 510(k). The device falls under product code OCW, Endoscopic Tissue Approximation Device, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 17, 2026. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Health Value Creation B.V. (trading as Corporis Medical) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262044?

K262044 is the FDA 510(k) for Mediclose Cartridge System, submitted by Health Value Creation B.V. (trading as Corporis Medical). FDA's decision date was Oct 14, 2026, under product code OCW (Endoscopic Tissue Approximation Device).

Who makes the Mediclose Cartridge System?

Health Value Creation B.V. (trading as Corporis Medical), based in Maastricht, is the applicant of record for K262044.

How long did the K262044 review take?

FDA received the submission on Jun 17, 2026 and issued its decision on Oct 14, 2026, 119 days later.

← All decisions in October 2026