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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2026 / K261649

510(k) cleared

Excelsior Reach Microcatheter

Stryker Neurovascular · Oct 9, 2026 · K261649

FDA cleared the Excelsior Reach Microcatheter from Stryker Neurovascular on Oct 9, 2026 under K261649, a traditional 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 19, 2026. The decision came 143 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stryker Neurovascular has 3 other decisions in the tracker over the last 12 months: K261889 (Trevo Trak 21 Microcatheter), K253032 (AXS Lift Intracranial Base Catheter), K252694 (Target Detachable Coil).

Questions & Answers

What did FDA clear under K261649?

K261649 is the FDA 510(k) for Excelsior Reach Microcatheter, submitted by Stryker Neurovascular. FDA's decision date was Oct 9, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the Excelsior Reach Microcatheter?

Stryker Neurovascular, based in Fremont, CA, is the applicant of record for K261649.

How long did the K261649 review take?

FDA received the submission on May 19, 2026 and issued its decision on Oct 9, 2026, 143 days later.

← All decisions in October 2026

Sources