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Pathfinder Endoscope Overtube
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref GI 110160-2ERef GI 085160-2E510(k) K230801Ref GI 065140-2E
Identity
- Device Name
- Pathfinder Endoscope Overtube EUDAMED
- Model / Reference
- GI 110160-2E EUDAMEDGI 085160-2E EUDAMEDGI 065140-2E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850006222186 EUDAMED00850006222179 EUDAMED00850006222131 EUDAMED
- Basic UDI-DI
- 0850006222PATHFINDEROTHZ EUDAMED
- 510(k) Number
- K230801 FDA 510(k)
- FDA Product Code
- FED FDA 510(k)
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tissue morcellation system handpiece, line-powered
Pathfinder Endoscope Overtube by Neptune Medical — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Tissue morcellation system handpiece, line-powered.
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230801 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0850006222PATHFINDEROTHZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Neptune Medical
- EUDAMED SRN
- US-MF-000039356
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (4)
- EUDAMED db1270e1-baea-4e0b-bcc9-67d7e2fce032 61 fields · synced Jul 20, 2026
- EUDAMED a070418f-a5ed-41ad-a3cf-bf98eed437a4 61 fields · synced May 17, 2026
- FDA 510(k) K230801 24 fields · synced May 18, 2026
- EUDAMED 8e7c2740-73ad-4029-b130-0deebfdd4e52 61 fields · synced Jul 10, 2026