WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K260652

510(k) cleared

ColActive Plus

Covalon Technologies, Ltd. · Sep 9, 2026 · K260652

FDA cleared the ColActive Plus from Covalon Technologies, Ltd. on Sep 9, 2026 under K260652, a traditional 510(k). The device falls under product code KGN, Wound Dressing With Animal-Derived Material(S) as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Feb 27, 2026. The decision came 194 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 Covalon Technologies, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260652?

K260652 is the FDA 510(k) for ColActive Plus, submitted by Covalon Technologies, Ltd.. FDA's decision date was Sep 9, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the ColActive Plus?

Covalon Technologies, Ltd., based in Mississauga, is the applicant of record for K260652.

How long did the K260652 review take?

FDA received the submission on Feb 27, 2026 and issued its decision on Sep 9, 2026, 194 days later.

← All decisions in September 2026