WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K252995

510(k) cleared

Durashield Device Kit

SurGenTec, LLC · Sep 17, 2026 · K252995

FDA cleared the Durashield Device Kit from SurGenTec, LLC on Sep 17, 2026 under K252995, a traditional 510(k). The device falls under product code GZT, Retractor, Self-Retaining, For Neurosurgery, regulated at 21 CFR 882.4800 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 18, 2025. The decision came 364 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SurGenTec, LLC has 7 other decisions in the tracker over the last 12 months: K262581 (GraftGun Universal Graft Delivery System (GDS®)), K261381 (TiLink-L SI Joint Fusion System), K262121 (Ion-L Navigated Instruments), K261209 (Ion-L).

Questions & Answers

What did FDA clear under K252995?

K252995 is the FDA 510(k) for Durashield Device Kit, submitted by SurGenTec, LLC. FDA's decision date was Sep 17, 2026, under product code GZT (Retractor, Self-Retaining, For Neurosurgery).

Who makes the Durashield Device Kit?

SurGenTec, LLC, based in Boca Raton, FL, is the applicant of record for K252995.

How long did the K252995 review take?

FDA received the submission on Sep 18, 2025 and issued its decision on Sep 17, 2026, 364 days later.

← All decisions in September 2026