LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
FDA 510(k) clearance K253134 · decided 2026-05-20
Clearance details
- K-number
- K253134
- Device name
- LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
- Applicant
- Lagis Enterprise Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-25
- Decision date
- 2026-05-20
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Taichung City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.