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FDA 510(k)

Pathfinder Endoscope Overtube with Balloon Device

K-Number: K230801 · 2023-07-28

ApplicantNeptune Medical, Inc.
Decision Date2023-07-28
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pathfinder Endoscope Overtube with Balloon Device 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 2023-07-28 under 510(k) number K230801. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pathfinder Endoscope Overtube with Balloon Device?

Pathfinder Endoscope Overtube with Balloon Device is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Neptune Medical, Inc.. The 510(k) number is K230801.

When did Pathfinder Endoscope Overtube with Balloon Device receive FDA 510(k) clearance?

Pathfinder Endoscope Overtube with Balloon Device received FDA 510(k) clearance on 2023-07-28, under 510(k) number K230801.

Who is the listed applicant for Pathfinder Endoscope Overtube with Balloon Device?

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 Overtube with Balloon Device?

The FDA product code for Pathfinder Endoscope Overtube with Balloon Device is FED.

Related Clinical Trials

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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 SystemK211301Pathfinder Endoscope OvertubeK210915Pathfinder Endoscope CapK191415Pathfinder Endoscope Overtube

Related Devices (Code: FED)

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.

K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.

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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