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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 / K260110

510(k) cleared

danumed Extension Set for Gastrostomy Button

Danumed Medizintechnik GmbH · Sep 10, 2026 · K260110

FDA cleared the danumed Extension Set for Gastrostomy Button from Danumed Medizintechnik GmbH on Sep 10, 2026 under K260110, a traditional 510(k). The device falls under product code PIF, Gastrointestinal Tubes With Enteral Specific Connectors, regulated at 21 CFR 876.5980 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jan 14, 2026. The decision came 239 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 Danumed Medizintechnik GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260110?

K260110 is the FDA 510(k) for danumed Extension Set for Gastrostomy Button, submitted by Danumed Medizintechnik GmbH. FDA's decision date was Sep 10, 2026, under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors).

Who makes the danumed Extension Set for Gastrostomy Button?

Danumed Medizintechnik GmbH, based in Regensburg, is the applicant of record for K260110.

How long did the K260110 review take?

FDA received the submission on Jan 14, 2026 and issued its decision on Sep 10, 2026, 239 days later.

← All decisions in September 2026