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 FDA UDI

Identifiers

Catalog Number: GI 085140 FDA UDI
Primary DI / UDI-DI: 00850006222001 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: 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

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Manufacturer

Manufacturer: Neptune Medical

Sources (1)

FDA UDI d094c175-60f2-4b0c-bebe-ba5aaaebd44d 36 fields · synced Jun 8, 2026