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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Submucosal Injection Agent
510(k) Number K260997
Device Name SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)
Applicant
Endoclot Plus Co., Ltd.
Unit 101, B8 Bldg., 218 Xinghu St. Suzhou Industrial Park
(Jiangsu) Pilot Free Trade Zone Suzhou Area
Suzhou,  CN 215000
Applicant Contact Huihui Xie
Correspondent
Microkn Medical Technology Service (Shanghai) Co., Ltd.
Rm. 901, Huafa Center, 889 Pinglu Rd., Jing 'An District
Shanghai,  CN 200040
Correspondent Contact Owen He
Regulation Number876.1500
Classification Product Code
PLL  
Date Received03/26/2026
Decision Date 09/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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