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.

Summary

SIS BLU comes from Endoclot Plus Co., Ltd. in two versions, SISBLU-30-01 and SISBLU-15-01, under product code PLL (Submucosal Injection Agent). The record doesn't say how the two differ.

Class II, 21 CFR 876.1500. Gastroenterology, Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.

Endoclot filed from Suzhou, China. The decision came 167 calendar days after receipt (March 26 to September 9, 2026).

Clearance details

Device name as filed: SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)
Applicant: Endoclot Plus Co., Ltd.
Product code: Product 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.