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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K262262

510(k) cleared

Pathfinder Endoscope Overtube

Neptune Medical, Inc. · Sep 18, 2026 · K262262 · In the directory

FDA cleared the Pathfinder Endoscope Overtube from Neptune Medical, Inc. on Sep 18, 2026 under K262262, a traditional 510(k). The device falls under product code FED, Endoscopic Access Overtube, Gastroenterology-Urology, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 2, 2026. The decision came 78 days later, inside the 90 FDA-day goal for a 510(k).

Neptune Medical, Inc. has one other decision in the tracker over the last 12 months: K260503 (Triton 1 System).

Questions & Answers

What did FDA clear under K262262?

K262262 is the FDA 510(k) for Pathfinder Endoscope Overtube, submitted by Neptune Medical, Inc.. FDA's decision date was Sep 18, 2026, under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology).

Who makes the Pathfinder Endoscope Overtube?

Neptune Medical, Inc., based in Burlingame, CA, is the applicant of record for K262262. The company is listed in the MedDevice Startups directory.

How long did the K262262 review take?

FDA received the submission on Jul 2, 2026 and issued its decision on Sep 18, 2026, 78 days later.

← All decisions in September 2026

Sources

In the startup directory

Neptune Medical

GI & Urology · Burlingame, CA