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THE TAPE

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 / K262050

510(k) cleared

Vioseal X

Spident Co., Ltd. · Sep 11, 2026 · K262050

FDA cleared the Vioseal X from Spident Co., Ltd. on Sep 11, 2026 under K262050, a traditional 510(k). The device falls under product code KIF, Resin, Root Canal Filling, regulated at 21 CFR 872.3820 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 18, 2026. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Spident Co., Ltd. has one other decision in the tracker over the last 12 months: K261129 (OrthoFit).

Questions & Answers

What did FDA clear under K262050?

K262050 is the FDA 510(k) for Vioseal X, submitted by Spident Co., Ltd.. FDA's decision date was Sep 11, 2026, under product code KIF (Resin, Root Canal Filling).

Who makes the Vioseal X?

Spident Co., Ltd., based in Incheon, is the applicant of record for K262050.

How long did the K262050 review take?

FDA received the submission on Jun 18, 2026 and issued its decision on Sep 11, 2026, 85 days later.

← All decisions in September 2026