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FDA 510(k)

LABORIE URODYNAMICS PROCESSOR

K-Number: K852856 · 1985-10-17

ApplicantTridak Division of Indicon, Inc.
Decision Date1985-10-17
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LABORIE URODYNAMICS PROCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Tridak Division of Indicon, Inc.. It received FDA 510(k) clearance on 1985-10-17 under 510(k) number K852856. The device is classified under product code FAP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABORIE URODYNAMICS PROCESSOR?

LABORIE URODYNAMICS PROCESSOR is a medical device that received FDA 510(k) clearance on 1985-10-17. The listed applicant is Tridak Division of Indicon, Inc.. The 510(k) number is K852856.

When did LABORIE URODYNAMICS PROCESSOR receive FDA 510(k) clearance?

LABORIE URODYNAMICS PROCESSOR received FDA 510(k) clearance on 1985-10-17, under 510(k) number K852856.

Who is the listed applicant for LABORIE URODYNAMICS PROCESSOR?

The FDA 510(k) record lists Tridak Division of Indicon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABORIE URODYNAMICS PROCESSOR?

The FDA product code for LABORIE URODYNAMICS PROCESSOR is FAP.

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Other records listing Tridak Division of Indicon, 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.

K891007NONIMPLANTED ELECTRICAL CONTINENCE DEVICEK860744OPTHALMIC SURGICAL INSTRUMENTSK853059LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACEK851934CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULAK842609R.L. MEDICAL TWIN LIGHT SOURCEK840605LABORIE FIBREOPTIC LIGHT CABLE

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Related Devices (Code: FAP)

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.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., 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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