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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 / November 2025 / K252664

510(k) cleared

GMReis Suture Anchors

GM Dos Reis Industria e Comercio Ltda. · Nov 4, 2025 · K252664

FDA cleared the GMReis Suture Anchors from GM Dos Reis Industria e Comercio Ltda. on Nov 4, 2025 under K252664, a traditional 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 22, 2025. The decision came 74 days later, inside the 90 FDA-day goal for a 510(k).

GM Dos Reis Industria e Comercio Ltda. has 6 other decisions in the tracker over the last 12 months: K253910 (Stitch - Suture Wires and Tapes), K262537 (Versalock Sterile Plating System), K261406 (Versalock Proximal Tibial Plating System), K260390 (Super Upper Limbs Versalock Plating System).

Questions & Answers

What did FDA clear under K252664?

K252664 is the FDA 510(k) for GMReis Suture Anchors, submitted by GM Dos Reis Industria e Comercio Ltda.. FDA's decision date was Nov 4, 2025, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the GMReis Suture Anchors?

GM Dos Reis Industria e Comercio Ltda., based in Campinas, is the applicant of record for K252664.

How long did the K252664 review take?

FDA received the submission on Aug 22, 2025 and issued its decision on Nov 4, 2025, 74 days later.

← All decisions in November 2025

Sources