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FDA 510(k)

FST CATH-UD CATHETER

K-Number: K905641 · 1991-02-19

ApplicantFiberoptic Sensor Technlogies, Inc.
Decision Date1991-02-19
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FST CATH-UD CATHETER 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 1991-02-19 under 510(k) number K905641. 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-UD CATHETER?

FST CATH-UD CATHETER is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is Fiberoptic Sensor Technlogies, Inc.. The 510(k) number is K905641.

When did FST CATH-UD CATHETER receive FDA 510(k) clearance?

FST CATH-UD CATHETER received FDA 510(k) clearance on 1991-02-19, under 510(k) number K905641.

Who is the listed applicant for FST CATH-UD CATHETER?

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-UD CATHETER?

The FDA product code for FST CATH-UD CATHETER 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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