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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 / K262277

510(k) cleared

70 NeuGlide Catheter

Piraeus Medical, Inc. · Sep 4, 2026 · K262277

FDA cleared the 70 NeuGlide Catheter from Piraeus Medical, Inc. on Sep 4, 2026 under K262277, a special 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 6, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Piraeus Medical, Inc. has one other decision in the tracker over the last 12 months: K260751 (35 Helix Guidewire).

Questions & Answers

What did FDA clear under K262277?

K262277 is the FDA 510(k) for 70 NeuGlide Catheter, submitted by Piraeus Medical, Inc.. FDA's decision date was Sep 4, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the 70 NeuGlide Catheter?

Piraeus Medical, Inc., based in Maple Grove, MN, is the applicant of record for K262277.

How long did the K262277 review take?

FDA received the submission on Jul 6, 2026 and issued its decision on Sep 4, 2026, 60 days later.

← All decisions in September 2026

Sources