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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 / April 2026 / K260573

510(k) cleared

EvoEndo Single-Use Endoscopy System

EvoEndo, Inc. · Apr 21, 2026 · K260573 · In the directory

FDA cleared the EvoEndo Single-Use Endoscopy System from EvoEndo, Inc. on Apr 21, 2026 under K260573, a traditional 510(k). The device falls under product code FDS, Gastroscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 20, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for EvoEndo, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260573?

K260573 is the FDA 510(k) for EvoEndo Single-Use Endoscopy System, submitted by EvoEndo, Inc.. FDA's decision date was Apr 21, 2026, under product code FDS (Gastroscope And Accessories, Flexible/Rigid).

Who makes the EvoEndo Single-Use Endoscopy System?

EvoEndo, Inc., based in Grayslake, IL, is the applicant of record for K260573. The company is listed in the MedDevice Startups directory.

How long did the K260573 review take?

FDA received the submission on Feb 20, 2026 and issued its decision on Apr 21, 2026, 60 days later.

← All decisions in April 2026

Sources

In the startup directory

EvoEndo

GI & Urology · Denver, CO