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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K261418

510(k) cleared

Liquick X-treme, Liquick X-treme Plus

Teleflex Medical · Sep 23, 2026 · K261418

FDA cleared the Liquick X-treme, Liquick X-treme Plus from Teleflex Medical on Sep 23, 2026 under K261418, a traditional 510(k). The device falls under product code EZD, Catheter, Straight, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 30, 2026. The decision came 146 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Teleflex Medical has 2 other decisions in the tracker over the last 12 months: K261988 (Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture), K260775 (Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape).

Questions & Answers

What did FDA clear under K261418?

K261418 is the FDA 510(k) for Liquick X-treme, Liquick X-treme Plus, submitted by Teleflex Medical. FDA's decision date was Sep 23, 2026, under product code EZD (Catheter, Straight).

Who makes the Liquick X-treme, Liquick X-treme Plus?

Teleflex Medical, based in Athlone, is the applicant of record for K261418.

How long did the K261418 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Sep 23, 2026, 146 days later.

← All decisions in September 2026

Sources