WHERE ARE YOU?

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

THE TAPE

Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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: K262151 (SpaceOAR Flex System), K262460 (Rezum System), K261153 (LithoVue Elite Digital Flexible Ureteroscope System), K253692 (AVVIGO+ Multi-Modality Guidance System).

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