Medical Device Manufacturer · US , Burlingame , CA

Neptune Medical, Inc. - FDA 510(k) Cleared Devices

7 submissions · 6 cleared · Since 2019

Recent clearances: Pathfinder Endoscope Overtube, Triton 1 System, Pathfinder® CR System

7
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Neptune Medical, Inc. Gastroenterology & Urology ✕

7 devices
1-7 of 7
Cleared Sep 18, 2026
Pathfinder Endoscope Overtube
K262262 · FED
Gastroenterology & Urology · 78d
Cleared Sep 03, 2026
Triton 1 System
K260503 · FDF
Gastroenterology & Urology · 198d
Cleared Jun 27, 2024
Pathfinder® CR System
K240853 · FED
Gastroenterology & Urology · 91d
Cleared Jul 28, 2023
Pathfinder Endoscope Overtube with Balloon Device
K230801 · FED
Gastroenterology & Urology · 127d
Cleared May 28, 2021
Pathfinder Endoscope Overtube
K211301 · FED
Gastroenterology & Urology · 29d
Cleared May 25, 2021
Pathfinder Endoscope Cap
K210915 · FDS
Gastroenterology & Urology · 57d
Cleared Aug 30, 2019
Pathfinder Endoscope Overtube
K191415 · FED
Gastroenterology & Urology · 94d
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