Pathfinder

FDA UDI

Class II (US FDA UDI)

by Neptune Medical

Identity

Trade Name: Pathfinder FDA UDI
Generic Name: Endoscopic overtube, single-use FDA UDI
Model / Reference: GI 085140-2 FDA UDI

Identifiers

Catalog Number: GI 085140-2 FDA UDI
Primary DI / UDI-DI: 00850006222018 FDA UDI
510(k) Number: K191415 FDA UDI
FDA Product Code: FED FDA UDI
GMDN Term: Endoscopic overtube, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Working Length — 75 Centimeter FDA UDI
Length — 85 Centimeter FDA UDI
Outer Diameter — 16.5 Millimeter FDA UDI

Category: Endoscopic overtube, single-use

Pathfinder by Neptune Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic overtube, single-use.

FUJIFILM — FUJIFILM Corporation · Class II
Guardus — US Endoscopy · Class II
Guardus — US Endoscopy · Class II
endomina platform — Endo Tools Therapeutics · Class II
FUJIFILM — FUJIFILM Corporation · Class II
Flexible Overtube — SB-KAWASUMI LABORATORIES, INC. · Class II
Ancora — ASPERO MEDICAL, INC. · Class II
Guardus — US Endoscopy · Class II

Cleared under the same submission

K191415 also covers:

Pathfinder® — Neptune Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Neptune Medical

Sources (1)

FDA UDI 3129373f-0e27-4c18-a96a-e6fe974f2c5c 36 fields · synced May 30, 2026