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.
Clearance details
- Applicant
- Medical Impact
- Product code
- 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
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- K260414 — Tech-Image Video Endoscope System
- K253994 — TroKit Laparoscope Lens Wiper
Adverse 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.