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FDA 510(k)

FST COUNCIL TIP FOLEY CATHETER

K-Number: K922776 · 1993-07-20

ApplicantFiberoptic Sensor Technlogies, Inc.
Decision Date1993-07-20
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FST COUNCIL TIP FOLEY 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 1993-07-20 under 510(k) number K922776. 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 COUNCIL TIP FOLEY CATHETER?

FST COUNCIL TIP FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1993-07-20. The listed applicant is Fiberoptic Sensor Technlogies, Inc.. The 510(k) number is K922776.

When did FST COUNCIL TIP FOLEY CATHETER receive FDA 510(k) clearance?

FST COUNCIL TIP FOLEY CATHETER received FDA 510(k) clearance on 1993-07-20, under 510(k) number K922776.

Who is the listed applicant for FST COUNCIL TIP FOLEY 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 COUNCIL TIP FOLEY CATHETER?

The FDA product code for FST COUNCIL TIP FOLEY 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 MONITORK922476URO-PRO 2000K926088FST CATH UD-DUAL DUAL PRESSURE CATHETER

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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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