K253541

EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)

510(k) number: K253541
Device name: EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
Applicant: Medical Impact KR
Product code: GCJ — Laparoscope, General & Plastic Surgery
Decision date: 2026-07-24
Date received: 2025-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

510(k) Summary (official FDA PDF): K253541.pdf

Official FDA record: K253541

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.