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FDA 510(k)

UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER

K-Number: K003580 · 2001-07-31

ApplicantUnisensor AG
Decision Date2001-07-31
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Unisensor AG. It received FDA 510(k) clearance on 2001-07-31 under 510(k) number K003580. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER?

UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER is a medical device that received FDA 510(k) clearance on 2001-07-31. The listed applicant is Unisensor AG. The 510(k) number is K003580.

When did UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER receive FDA 510(k) clearance?

UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER received FDA 510(k) clearance on 2001-07-31, under 510(k) number K003580.

Who is the listed applicant for UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER?

The FDA 510(k) record lists Unisensor AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER?

The FDA product code for UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER is FFX.

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.

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Other records listing Unisensor AG 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.

K062222UNITIP HIGH RESOLUTION CATHETER

Related Devices (Code: FFX)

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.

K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLCK240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.K231861EndoflipTM 300 SystemCovidien, LLCK223705EndoflipTM 300Covidien, LLCK222000Transit-PelletsMedifactia ABK201106IntraMarX 3D Radiopaque MarkerAnx Robotica Corp

Official Source

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