Cleared Traditional

K262262 - Pathfinder Endoscope Overtube

K262262 is an FDA 510(k) clearance for Pathfinder Endoscope Overtube, manufactured by Neptune Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K262262 · Neptune Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
78d
Days
Class 2
Risk

K262262 is an FDA 510(k) clearance for the Pathfinder Endoscope Overtube. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Neptune Medical, Inc. (Burlingame, US). The FDA issued a Cleared decision on September 18, 2026 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neptune Medical, Inc. devices

FDA 510(k) Submission Details - K262262

510(k) Number K262262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2026
Decision Date September 18, 2026
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 131d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FED Device Classification - Class 2, Special Controls

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

AlvaMed, Inc.
Keira Jessop

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FED Endoscopic Access Overtube, Gastroenterology-urology

All 95
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