Laport— 510(k) K252985
Substantially EquivalentSejong Medical Co., Ltd.
FDA 510(k) clearance K252985 for Laport, Substantially Equivalent on 2026-05-19. Applicant: Sejong Medical Co., Ltd.. Device class: 2.
Summary
Sejong Medical's Laport is filed under GCJ, general and plastic surgery laparoscopes. The record doesn't describe it beyond its name and that code name.
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.
Sejong filed from Paju-Si, South Korea. Review took 243 calendar days (September 18, 2025 to May 19, 2026).
Clearance details
- Applicant
- Sejong Medical Co., Ltd.
- 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
- Paju-Si, KR
Recent devices under product code GCJ
view allMore clearances from Sejong Medical Co., Ltd.
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.