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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K260997

510(k) cleared

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

Endoclot Plus Co., Ltd. · Sep 9, 2026 · K260997

FDA cleared the SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) from Endoclot Plus Co., Ltd. on Sep 9, 2026 under K260997, a traditional 510(k). The device falls under product code PLL, Submucosal Injection Agent, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 26, 2026. The decision came 167 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Endoclot Plus Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260997?

K260997 is the FDA 510(k) for SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01), submitted by Endoclot Plus Co., Ltd.. FDA's decision date was Sep 9, 2026, under product code PLL (Submucosal Injection Agent).

Who makes the SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)?

Endoclot Plus Co., Ltd., based in Suzhou, is the applicant of record for K260997.

How long did the K260997 review take?

FDA received the submission on Mar 26, 2026 and issued its decision on Sep 9, 2026, 167 days later.

← All decisions in September 2026