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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 / K261543

510(k) cleared

Phasix ST Parastomal Hernia Mesh

Davol, Inc., A Subsidiary of C.R. Bard, Inc. · Sep 28, 2026 · K261543

FDA cleared the Phasix ST Parastomal Hernia Mesh from Davol, Inc., A Subsidiary of C.R. Bard, Inc. on Sep 28, 2026 under K261543, a traditional 510(k). The device falls under product code OWT, Mesh, Surgical, Absorbable, Abdominal Hernia, 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 May 8, 2026. The decision came 143 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 Davol, Inc., A Subsidiary of C.R. Bard, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261543?

K261543 is the FDA 510(k) for Phasix ST Parastomal Hernia Mesh, submitted by Davol, Inc., A Subsidiary of C.R. Bard, Inc.. FDA's decision date was Sep 28, 2026, under product code OWT (Mesh, Surgical, Absorbable, Abdominal Hernia).

Who makes the Phasix ST Parastomal Hernia Mesh?

Davol, Inc., A Subsidiary of C.R. Bard, Inc., based in Warwick, RI, is the applicant of record for K261543.

How long did the K261543 review take?

FDA received the submission on May 8, 2026 and issued its decision on Sep 28, 2026, 143 days later.

← All decisions in September 2026