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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 / May 2026 / K253530

510(k) cleared

Trexon Monofilament Synthetic Absorbable Suture

Medtronic · May 28, 2026 · K253530

FDA cleared the Trexon Monofilament Synthetic Absorbable Suture from Medtronic on May 28, 2026 under K253530, a traditional 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 Nov 13, 2025. The decision came 196 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic has 8 other decisions in the tracker over the last 12 months: K262913 (Protégé EverFlex Self-expanding Peripheral Stent System), K262735 (LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)), K262005 (Affera Integrated Mapping System), K261335 (VitalFlow Set with Balance Biosurface).

Questions & Answers

What did FDA clear under K253530?

K253530 is the FDA 510(k) for Trexon Monofilament Synthetic Absorbable Suture, submitted by Medtronic. FDA's decision date was May 28, 2026, under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid).

Who makes the Trexon Monofilament Synthetic Absorbable Suture?

Medtronic, based in North Haven, CT, is the applicant of record for K253530.

How long did the K253530 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on May 28, 2026, 196 days later.

← All decisions in May 2026