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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 / K262547

510(k) cleared

KARL STORZ TIPCAM1 Rubina

KALR STORZ SE & Co. KG · Sep 21, 2026 · K262547

FDA cleared the KARL STORZ TIPCAM1 Rubina from KALR STORZ SE & Co. KG on Sep 21, 2026 under K262547, a traditional 510(k). The device falls under product code OWN, Confocal Optical Imaging, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 23, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for KALR STORZ SE & Co. KG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262547?

K262547 is the FDA 510(k) for KARL STORZ TIPCAM1 Rubina, submitted by KALR STORZ SE & Co. KG. FDA's decision date was Sep 21, 2026, under product code OWN (Confocal Optical Imaging).

Who makes the KARL STORZ TIPCAM1 Rubina?

KALR STORZ SE & Co. KG, based in Tuttlingen, is the applicant of record for K262547.

How long did the K262547 review take?

FDA received the submission on Jul 23, 2026 and issued its decision on Sep 21, 2026, 60 days later.

← All decisions in September 2026