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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K261978

510(k) cleared

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System

Boston Scientific Corporation · Jul 10, 2026 · K261978

FDA cleared the WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System from Boston Scientific Corporation on Jul 10, 2026 under K261978, a special 510(k). The device falls under product code ESW, Prosthesis, Esophageal, regulated at 21 CFR 878.3610 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 12, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Boston Scientific Corporation has 8 other decisions in the tracker over the last 12 months: K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261488 (OBSIDIO Conformable Embolic), K262165 (FARADRIVE Steerable Sheath (M004PF21M402)), K262462 (TheraSphere 360 Y-90 Management Platform).

Questions & Answers

What did FDA clear under K261978?

K261978 is the FDA 510(k) for WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System, submitted by Boston Scientific Corporation. FDA's decision date was Jul 10, 2026, under product code ESW (Prosthesis, Esophageal).

Who makes the WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System?

Boston Scientific Corporation, based in Marlboro, MA, is the applicant of record for K261978.

How long did the K261978 review take?

FDA received the submission on Jun 12, 2026 and issued its decision on Jul 10, 2026, 28 days later.

← All decisions in July 2026