510(k) clearances

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

Endoclot Plus Co., Ltd. · Gastroenterology, Urology

K260997Substantially EquivalentTraditionalPLL
Open FDA's page for this record
Third party flag
N
City
Suzhou
Advisory committee description
Gastroenterology, Urology
Address 1
Unit 101, B8 Bldg., 218 Xinghu St. Suzhou Industrial Park
Address 2
(Jiangsu) Pilot Free Trade Zone Suzhou Area
Statement or summary
Summary
Product code
PLL
Zip code
215000
Applicant
Endoclot Plus Co., Ltd.
Decision date
2026-09-09
Decision code
SESE
Country code
CN
Device name
SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)
Advisory committee
GU
Contact
Huihui Xie
K number
K260997
Date received
2026-03-26
Review advisory committee
GU
Postal code
215000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Submucosal Injection Agent
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1500
Device class
2
Registration number
3006696607, 1528319, 3008720584, 3013911864, 3008132411, 3012099114, 3013155768, 3004837686, 9681630, 3013734919, 3005099803, 3013440400, 3014718111
FEI number
3006696607, 1000122656, 3008720584, 3013911864, 3008132411, 3012099114, 3013155768, 3004837686, 3002808845, 3013734919, 1000121355, 3005099803, 3013440400
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.