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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 / K261783

510(k) cleared

Plenity-V (MC0979 / GS110)

Gelesis SRL · Oct 2, 2026 · K261783

FDA cleared the Plenity-V (MC0979 / GS110) from Gelesis SRL on Oct 2, 2026 under K261783, a traditional 510(k). The device falls under product code QFQ, Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss, regulated at 21 CFR 876.5982 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 29, 2026. The decision came 126 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 Gelesis SRL in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261783?

K261783 is the FDA 510(k) for Plenity-V (MC0979 / GS110), submitted by Gelesis SRL. FDA's decision date was Oct 2, 2026, under product code QFQ (Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss).

Who makes the Plenity-V (MC0979 / GS110)?

Gelesis SRL, based in Calimera, is the applicant of record for K261783.

How long did the K261783 review take?

FDA received the submission on May 29, 2026 and issued its decision on Oct 2, 2026, 126 days later.

← All decisions in October 2026