ClearanceBrief
Company · US

Neptune Medical, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.

7510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
FEDEndoscopic Access Overtube, Gastroenterology-Urology5
FDFColonoscope And Accessories, Flexible/Rigid1
FDSGastroscope And Accessories, Flexible/Rigid1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 18, 2026K262262Pathfinder Endoscope Overtube
Neptune Medical, Inc.
FED
Sep 3, 2026K260503Triton 1 System
Neptune Medical, Inc.
FDF
Jun 27, 2024K240853Pathfinder® CR System
Neptune Medical, Inc.
FED
Jul 28, 2023K230801Pathfinder Endoscope Overtube with Balloon Device
Neptune Medical, Inc.
FED
May 28, 2021K211301Pathfinder Endoscope Overtube
Neptune Medical, Inc.
FED
May 25, 2021K210915Pathfinder Endoscope Cap
Neptune Medical, Inc.
FDS
Aug 30, 2019K191415Pathfinder Endoscope Overtube
Neptune Medical, Inc.
FED

Latest recalls

DateFirm and productCodeLinked 510(k)
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