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FDA 510(k)

Pathfinder® CR System

K-Number: K240853 · 2024-06-27

ApplicantNeptune Medical, Inc.
Decision Date2024-06-27
Product CodeFED
Advisory CommitteeGU
DecisionUnknown

Device Summary

Pathfinder® CR 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 2024-06-27 under 510(k) number K240853. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Pathfinder® CR System?

Pathfinder® CR System is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Neptune Medical, Inc.. The 510(k) number is K240853.

When did Pathfinder® CR System receive FDA 510(k) clearance?

Pathfinder® CR System received FDA 510(k) clearance on 2024-06-27, under 510(k) number K240853.

Who is the listed applicant for Pathfinder® CR 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 Pathfinder® CR System?

The FDA product code for Pathfinder® CR System is FED.

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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.

K230801Pathfinder Endoscope Overtube with Balloon DeviceK211301Pathfinder 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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