Pathfinder Endoscope Overtube— 510(k) K262262
Substantially EquivalentNeptune Medical, Inc.
FDA 510(k) clearance K262262 for Pathfinder Endoscope Overtube, Substantially Equivalent on 2026-09-18. Applicant: Neptune Medical, Inc.. Device class: 2.
Summary
Neptune Medical, Inc. submitted the Pathfinder Endoscope Overtube under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology). The record doesn't describe the overtube beyond its name and code.
Class II, 21 CFR 876.1500. Gastroenterology, Urology is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
Neptune filed from Burlingame, California. The decision came 78 calendar days after receipt (July 2 to September 18, 2026).
Clearance details
- Applicant
- Neptune Medical, Inc.
- Product code
- Product code FED
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlingame, CA, US
Recent devices under product code FED
view allMore clearances from Neptune Medical, Inc.
view allAdverse events under product code FED
product code FED- Death
- 10
- Total
- 10
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.