510(k) clearance

SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)

FDA 510(k) source

510(k) number

K260997

Applicant

Endoclot Plus Co., Ltd.

Decision date

Sep 9, 2026

Date received

Mar 26, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

PLL

Device type

Submucosal Injection Agent

Device class

Class II

Regulation

21 CFR 876.1500

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Suzhou, CN