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FDA 510(k)

ETUDE, URODYNAMIC INVESTIGATION SYSTEM

K-Number: K901494 · 1990-10-26

ApplicantDantec Medical, Inc.
Decision Date1990-10-26
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ETUDE, URODYNAMIC INVESTIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Medical, Inc.. It received FDA 510(k) clearance on 1990-10-26 under 510(k) number K901494. 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 ETUDE, URODYNAMIC INVESTIGATION SYSTEM?

ETUDE, URODYNAMIC INVESTIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1990-10-26. The listed applicant is Dantec Medical, Inc.. The 510(k) number is K901494.

When did ETUDE, URODYNAMIC INVESTIGATION SYSTEM receive FDA 510(k) clearance?

ETUDE, URODYNAMIC INVESTIGATION SYSTEM received FDA 510(k) clearance on 1990-10-26, under 510(k) number K901494.

Who is the listed applicant for ETUDE, URODYNAMIC INVESTIGATION SYSTEM?

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

What is the FDA product code for ETUDE, URODYNAMIC INVESTIGATION SYSTEM?

The FDA product code for ETUDE, URODYNAMIC INVESTIGATION SYSTEM is FAP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dantec Medical, 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.

K960503DANTEC DUETK950314DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)K953999DANTEC DA CAPOK926363MULTI-DOP SK931801MULTI-DOP XK930458MULTI-DOP L

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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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