WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Theraclion wins a De Novo for treating varicose veins with focused ultrasound Onkos Surgical extends its antibacterial coating to more ELEOS titanium parts Siemens Healthineers names its diagnostics carve-out Olyrian and sets mid-2028 FX Shoulder clears the first stemless reverse shoulder system sold in the US Edwards raises its 2026 outlook a third time on $1.24B of TAVR sales CMS pays non-contrast imaging the same rate in hospitals and offices from 2027 Mobia Medical lifts 2026 guidance after a 73 percent revenue quarter PulseAI clears an arrhythmia model that reads single-lead ECG from wearables Baird Medical's partner files a 510(k) for an irreversible electroporation system Theraclion wins a De Novo for treating varicose veins with focused ultrasound Onkos Surgical extends its antibacterial coating to more ELEOS titanium parts Siemens Healthineers names its diagnostics carve-out Olyrian and sets mid-2028 FX Shoulder clears the first stemless reverse shoulder system sold in the US Edwards raises its 2026 outlook a third time on $1.24B of TAVR sales CMS pays non-contrast imaging the same rate in hospitals and offices from 2027 Mobia Medical lifts 2026 guidance after a 73 percent revenue quarter PulseAI clears an arrhythmia model that reads single-lead ECG from wearables Baird Medical's partner files a 510(k) for an irreversible electroporation system

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.

Danumed Medizintechnik GmbH has one other decision in the tracker over the last 12 months: K262038 (danumed StomaMeter).

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

Sources