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StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid

The Tracker / September 2026 / K261311

510(k) cleared

HYALOMATRIX

Anika Therapeutics, Inc. · Sep 2, 2026 · K261311

FDA cleared the HYALOMATRIX from Anika Therapeutics, Inc. on Sep 2, 2026 under K261311, a traditional 510(k). The device falls under product code QSZ, Absorbable Synthetic Wound Dressing as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Apr 21, 2026. The decision came 134 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Anika Therapeutics, Inc. has one other decision in the tracker over the last 12 months: K261869 (Integrity Retractable Implant Inserter (6000127)).

Questions & Answers

What did FDA clear under K261311?

K261311 is the FDA 510(k) for HYALOMATRIX, submitted by Anika Therapeutics, Inc.. FDA's decision date was Sep 2, 2026, under product code QSZ (Absorbable Synthetic Wound Dressing).

Who makes the HYALOMATRIX?

Anika Therapeutics, Inc., based in Beford, MA, is the applicant of record for K261311.

How long did the K261311 review take?

FDA received the submission on Apr 21, 2026 and issued its decision on Sep 2, 2026, 134 days later.

← All decisions in September 2026

Sources