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FDA 510(k)

Pathfinder Endoscope Cap

K-Number: K210915 · 2021-05-25

ApplicantNeptune Medical, Inc.
Decision Date2021-05-25
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pathfinder Endoscope Cap 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 2021-05-25 under 510(k) number K210915. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pathfinder Endoscope Cap?

Pathfinder Endoscope Cap is a medical device that received FDA 510(k) clearance on 2021-05-25. The listed applicant is Neptune Medical, Inc.. The 510(k) number is K210915.

When did Pathfinder Endoscope Cap receive FDA 510(k) clearance?

Pathfinder Endoscope Cap received FDA 510(k) clearance on 2021-05-25, under 510(k) number K210915.

Who is the listed applicant for Pathfinder Endoscope Cap?

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 Pathfinder Endoscope Cap?

The FDA product code for Pathfinder Endoscope Cap is FDS.

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 OvertubeK191415Pathfinder Endoscope Overtube

Related Devices (Code: FDS)

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.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm CorporationK253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm CorporationK251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)Pentax of America, Inc.K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, Inc.

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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