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FDA 510(k)

Triton 1 System

K-Number: K260503 · 2026-09-03

ApplicantNeptune Medical, Inc.
Decision Date2026-09-03
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Triton 1 System is the device name listed in this FDA 510(k) record. The listed applicant is Neptune Medical, Inc.. It received FDA 510(k) clearance on 2026-09-03 under 510(k) number K260503. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Triton 1 System?

Triton 1 System is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Neptune Medical, Inc.. The 510(k) number is K260503.

When did Triton 1 System receive FDA 510(k) clearance?

Triton 1 System received FDA 510(k) clearance on 2026-09-03, under 510(k) number K260503.

Who is the listed applicant for Triton 1 System?

The FDA 510(k) record lists Neptune Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triton 1 System?

The FDA product code for Triton 1 System is FDF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06571760Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-ICOMPLETEDNCT07606963Triton 1.5 Robotic System for Diagnostic ColonoscopyNOT_YET_RECRUITING

Other records listing Neptune Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240853Pathfinder® CR SystemK230801Pathfinder Endoscope Overtube with Balloon DeviceK211301Pathfinder Endoscope OvertubeK210915Pathfinder Endoscope CapK191415Pathfinder Endoscope Overtube

Related Devices (Code: FDF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261015Solo Scope Colonoscope SystemGi View, Ltd.K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFujifilm Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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