LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)— 510(k) K253134
Substantially EquivalentLagis Enterprise Co., Ltd.
FDA 510(k) clearance K253134 for LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T), Substantially Equivalent on 2026-05-20. Applicant: Lagis Enterprise Co., Ltd.. Device class: 2.
Summary
Lagis Enterprise's LAGIS Endoscopic Instruments, Scissors, are listed with four model numbers (EI-330S, EI-330S-T, EI-330MS, EI-330MS-T) under GEI, electrosurgical cutting and coagulation devices and accessories.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
Lagis filed from Taichung City, Taiwan. Review took 237 calendar days (September 25, 2025 to May 20, 2026).
Clearance details
- Applicant
- Lagis Enterprise Co., Ltd.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, TW
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More clearances from Lagis Enterprise Co., Ltd.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.