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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 / K262460

510(k) cleared

Rezum System

Boston Scientific · Sep 3, 2026 · K262460

FDA cleared the Rezum System from Boston Scientific on Sep 3, 2026 under K262460, a traditional 510(k). The device falls under product code KNS, Unit, Electrosurgical, Endoscopic (With Or Without Accessories), regulated at 21 CFR 876.4300 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 17, 2026. The decision came 48 days later, inside the 90 FDA-day goal for a 510(k).

Boston Scientific has 8 other decisions in the tracker over the last 12 months: K261153 (LithoVue Elite Digital Flexible Ureteroscope System), K253692 (AVVIGO+ Multi-Modality Guidance System), K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261915 (Navigator Flex Ureteral Access Sheath Set).

Questions & Answers

What did FDA clear under K262460?

K262460 is the FDA 510(k) for Rezum System, submitted by Boston Scientific. FDA's decision date was Sep 3, 2026, under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)).

Who makes the Rezum System?

Boston Scientific, based in Marlborough, MA, is the applicant of record for K262460.

How long did the K262460 review take?

FDA received the submission on Jul 17, 2026 and issued its decision on Sep 3, 2026, 48 days later.

← All decisions in September 2026