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FDA 510(k)

FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM

K-Number: K913721 · 1991-10-08

ApplicantFiberoptic Sensor Technlogies, Inc.
Decision Date1991-10-08
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fiberoptic Sensor Technlogies, Inc.. It received FDA 510(k) clearance on 1991-10-08 under 510(k) number K913721. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM?

FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-08. The listed applicant is Fiberoptic Sensor Technlogies, Inc.. The 510(k) number is K913721.

When did FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM receive FDA 510(k) clearance?

FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM received FDA 510(k) clearance on 1991-10-08, under 510(k) number K913721.

Who is the listed applicant for FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM?

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

What is the FDA product code for FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM?

The FDA product code for FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM is FEN.

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Other records listing Fiberoptic Sensor Technlogies, 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.

K945753FST FIBEROPTIC PRESSURE CONVERTERK950908FST CATH-UD, CATHETERK9454954-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTIONK930171FST DUAL, DUAL PRESSURE URODYNAMICS MONITORK922776FST COUNCIL TIP FOLEY CATHETERK922476URO-PRO 2000

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Related Devices (Code: FEN)

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.

K212830CT3000ProSrs MedicalK082701URONIRS, MODEL 2000Urodynamix Technologies, Ltd.K073552LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORYLaborie Medical Technologies, Corp.K001386ACCUSET SENSOR, MODEL 2000Pelvicare, Inc.K992715NEURO URODYNAMIC SUITE, MODEL 9032E0101Medtronic Functional Diagnostics A/SK983325IN-PROBE II URODYNAMIC SYSTEMInfluence, 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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