Pathfinder GI 085140-2
Pathfinder GI 085140-2 is a Class II device made by Neptune Medical, cleared under FDA 510(k) K191415 on 30 Aug 2019 and listed in FDA GUDID since 28 Jan 2021 (UDI-DI 00850006222018), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850006222018 | Date28 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191415 | Date30 Aug 2019 | StatusActive |
Official records
- AccessGUDID record 00850006222018
- FDA 510(k) database K191415
Across registries
- FDA 510(k) K191415 decided 30 Aug 2019 Active
- FDA GUDID UDI-DI 00850006222018 listed 28 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K191415
- Listed FDA GUDID 00850006222018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pathfinder
- Generic name
- Endoscopic overtube, single-use
- Model / Ref / Catalog
- GI 085140-2
- Primary DI / UDI-DI
- 00850006222018
- 510(k) Number
- FDA product code
- FED
- GMDN term
- Endoscopic overtube, single-use
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Working Length — 75 CentimeterLength — 85 CentimeterOuter Diameter — 16.5 Millimeter
Similar devices in this category
Other devices filed under Endoscopic overtube, single-use.