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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K262315

510(k) cleared

NeuroBlate System

Monteris Medical · Sep 3, 2026 · K262315

FDA cleared the NeuroBlate System from Monteris Medical on Sep 3, 2026 under K262315, a traditional 510(k). The device falls under product code ONO, Neurosurgical Laser With Mr Thermography, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 8, 2026. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

Monteris Medical has one other decision in the tracker over the last 12 months: K260976 (NeuroBlate System).

Questions & Answers

What did FDA clear under K262315?

K262315 is the FDA 510(k) for NeuroBlate System, submitted by Monteris Medical. FDA's decision date was Sep 3, 2026, under product code ONO (Neurosurgical Laser With Mr Thermography).

Who makes the NeuroBlate System?

Monteris Medical, based in Minnetonka, MN, is the applicant of record for K262315.

How long did the K262315 review take?

FDA received the submission on Jul 8, 2026 and issued its decision on Sep 3, 2026, 57 days later.

← All decisions in September 2026

Sources