SIS BLU (SISBLU-30-01); SIS BLU (SISBLU-15-01)— 510(k) K260997

Name: FDA 510(k) clearance K260997
Creator: U.S. Food and Drug Administration
Published: 2026-09-09

Substantially Equivalent

Endoclot Plus Co., Ltd.

FDA 510(k) clearance K260997 for SIS BLU (SISBLU-30-01); SIS BLU (SISBLU-15-01), Substantially Equivalent on 2026-09-09. Applicant: Endoclot Plus Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)
Applicant: Endoclot Plus Co., Ltd.
Product code: Code PLL
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-03-26
Decision date: 2026-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.