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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 / K260474

510(k) cleared

Liora Monofilament Scaffold

TELA Bio, Inc. · Sep 28, 2026 · K260474

FDA cleared the Liora Monofilament Scaffold from TELA Bio, Inc. on Sep 28, 2026 under K260474, a traditional 510(k). The device falls under product code FTL, Mesh, Surgical, Polymeric, regulated at 21 CFR 878.3300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Feb 12, 2026. The decision came 228 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 TELA Bio, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260474?

K260474 is the FDA 510(k) for Liora Monofilament Scaffold, submitted by TELA Bio, Inc.. FDA's decision date was Sep 28, 2026, under product code FTL (Mesh, Surgical, Polymeric).

Who makes the Liora Monofilament Scaffold?

TELA Bio, Inc., based in Malvern, PA, is the applicant of record for K260474.

How long did the K260474 review take?

FDA received the submission on Feb 12, 2026 and issued its decision on Sep 28, 2026, 228 days later.

← All decisions in September 2026