FDA 510(k) clearance · back to tracker

LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)

Lagis Enterprise Co., Ltd. cleared K253134 on 2026-05-20, decision: substantially equivalent

K-number

K253134

Sponsor

Lagis Enterprise Co., Ltd.

Device

LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-20

Product code

GEI

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K253134on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.