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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 / September 2026 / K263073

510(k) cleared

Fast Absorbing PGLA

Riverpoint Medical, LLC · Sep 29, 2026 · K263073

FDA cleared the Fast Absorbing PGLA from Riverpoint Medical, LLC on Sep 29, 2026 under K263073, a special 510(k). The device falls under product code GAM, Suture, Absorbable, Synthetic, Polyglycolic Acid, regulated at 21 CFR 878.4493 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 1, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Riverpoint Medical, LLC has 3 other decisions in the tracker over the last 12 months: K262677 (Iconix Knotless T), K253693 (Strut Suture; No-Tie Button), K253695 (LigaMend).

Questions & Answers

What did FDA clear under K263073?

K263073 is the FDA 510(k) for Fast Absorbing PGLA, submitted by Riverpoint Medical, LLC. FDA's decision date was Sep 29, 2026, under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid).

Who makes the Fast Absorbing PGLA?

Riverpoint Medical, LLC, based in Portland, OR, is the applicant of record for K263073.

How long did the K263073 review take?

FDA received the submission on Sep 1, 2026 and issued its decision on Sep 29, 2026, 28 days later.

← All decisions in September 2026

Sources