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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K261070

510(k) cleared

LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated

Covidien, LLC · Sep 15, 2026 · K261070

FDA cleared the LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated from Covidien, LLC on Sep 15, 2026 under K261070, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Apr 1, 2026. The decision came 167 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Covidien, LLC has 8 other decisions in the tracker over the last 12 months: K260907 (BIS Advance pEEG Module), K253527 (Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)), K253984 (Instrument Exit Point on Touch Surgery Aide), K253030 (Capnostream35 Portable Respiratory Monitor (PM35MN)).

Questions & Answers

What did FDA clear under K261070?

K261070 is the FDA 510(k) for LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated, submitted by Covidien, LLC. FDA's decision date was Sep 15, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated?

Covidien, LLC, based in Lafayette, CO, is the applicant of record for K261070.

How long did the K261070 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Sep 15, 2026, 167 days later.

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