EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)— 510(k) K253541
Substantially EquivalentMedical Impact
FDA 510(k) clearance K253541 for EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device), Substantially Equivalent on 2026-07-24. Applicant: Medical Impact. Device class: 2.
Summary
Medical Impact's EZ-Close covers three port site closing devices: EZ Close, EZ Close MAX, and EZ Close II. They're filed under GCJ, laparoscopes for general and plastic surgery, and the record doesn't say how the three differ.
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Medical Impact filed from Gyeonggi-do, South Korea. Review took 252 calendar days (November 14, 2025 to July 24, 2026).
Clearance details
- Applicant
- Medical Impact
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gyeonggi-Do, KR
Recent devices under product code GCJ
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.