Cleared Traditional

Pathfinder Endoscope Overtube (K191415) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191415 · Neptune Medical, Inc. · Gastroenterology & Urology device
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Aug 2019
Decision
94d
Days
Class 2
Risk

K191415 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 August 30, 2019 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neptune Medical, Inc. devices

Submission Details

510(k) Number K191415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2019
Decision Date August 30, 2019
Days to Decision 94 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
36d faster than avg
Panel avg: 130d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.
Ian Broome

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 48
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K191415.
Dornier MAGELLAN Ureteral Access Sheath
K201815 · Dornier Medtech America, Inc. · Nov 2020
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K200419 · Kalera Medical, Inc. · May 2020
PatCom Single-Use Introducer
K192691 · H&A Mui Enterprises, Inc. · Feb 2020
Arc Endocuff Glide AEG110 & AEG120
K191067 · Boddingtons Plastics, Ltd. · May 2019
Peel-Away Introducer
K182403 · Cook Incorporated · May 2019
Flexible Overtube
K182520 · Sumitomo Bakelite Co., Ltd. · May 2019