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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

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.

This is the only decision on file for Anika Therapeutics, Inc. in the last 12 months of the tracker.

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