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FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics 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 Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics 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 Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Tracker / October 2026 / K261245

510(k) cleared

Restrata

Acera Surgical, Inc. · Oct 16, 2026 · K261245

FDA cleared the Restrata from Acera Surgical, Inc. on Oct 16, 2026 under K261245, a traditional 510(k). The device falls under product code QSZ, Absorbable Synthetic Wound Dressing as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Apr 16, 2026. The decision came 183 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 Acera Surgical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261245?

K261245 is the FDA 510(k) for Restrata, submitted by Acera Surgical, Inc.. FDA's decision date was Oct 16, 2026, under product code QSZ (Absorbable Synthetic Wound Dressing).

Who makes the Restrata?

Acera Surgical, Inc., based in St. Louis, MO, is the applicant of record for K261245.

How long did the K261245 review take?

FDA received the submission on Apr 16, 2026 and issued its decision on Oct 16, 2026, 183 days later.

← All decisions in October 2026