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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K253134
Device Name LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
Applicant
Lagis Enterprise Co., Ltd.
# 29, Gong 1st Rd., Dajia Dist.
Taichung City,  TW 43762
Applicant Contact Lynn Chen
Correspondent
Lagis Enterprise Co., Ltd.
# 29, Gong 1st Rd., Dajia Dist.
Taichung City,  TW 43762
Correspondent Contact Lynn Chen
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/25/2025
Decision Date 05/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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