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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 / K260117

510(k) cleared

Everslide

Special Situations, LLC · Sep 23, 2026 · K260117

FDA cleared the Everslide from Special Situations, LLC on Sep 23, 2026 under K260117, a traditional 510(k). The device falls under product code NUC, Lubricant, Personal, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jan 14, 2026. The decision came 252 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 Special Situations, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260117?

K260117 is the FDA 510(k) for Everslide, submitted by Special Situations, LLC. FDA's decision date was Sep 23, 2026, under product code NUC (Lubricant, Personal).

Who makes the Everslide?

Special Situations, LLC, based in Tulsa, OK, is the applicant of record for K260117.

How long did the K260117 review take?

FDA received the submission on Jan 14, 2026 and issued its decision on Sep 23, 2026, 252 days later.

← All decisions in September 2026