NEPTUNE MEDICAL, INC

FDA Device Registration & Listing · Burlingame, CA, US · Registration 3015451828

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015451828
FEI Number
3015451828
Entity Name
NEPTUNE MEDICAL, INC
City/State/Country
Burlingame, CA, US
Establishment Address
1828 El Camino Real, 5th Floor, Burlingame, CA 94010, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Neptune Medical, Inc (Owner Number: 10061389)
Owner / Operator Contact Address
1828 El Camino Real, Suite 508, Burlingame, CA 94010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230801
PMA Number
N/A

All Registered Proprietary Names

Pathfinder CR System Tape Cut Guide Pathfinder SB

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-07-03
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-07-03
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2021-05-26
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-08-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neptune Medical, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K232314 FUJIFILM Healthcare Americas Corporation Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) 2023-09-01
K230752 FUJIFILM Healthcare Americas Corporation Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) 2023-09-15

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2020550 KARL STORZ ENDOSCOPY-AMERICA, INC. Auburn, MA, US
3015136743 STERI-TECH CO.,LTD. KAZO-SHI Saitama, JP
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015451828. Last updated year: 2026. Please use registration number 3015451828 when referencing this establishment in official correspondence.
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