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FDA 510(k)

UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK

K-Number: K844503 · 1985-01-02

ApplicantEpcom Medical Systems, Inc.
Decision Date1985-01-02
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK is the device name listed in this FDA 510(k) record. The listed applicant is Epcom Medical Systems, Inc.. It received FDA 510(k) clearance on 1985-01-02 under 510(k) number K844503. 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 UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK?

UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK is a medical device that received FDA 510(k) clearance on 1985-01-02. The listed applicant is Epcom Medical Systems, Inc.. The 510(k) number is K844503.

When did UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK receive FDA 510(k) clearance?

UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK received FDA 510(k) clearance on 1985-01-02, under 510(k) number K844503.

Who is the listed applicant for UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK?

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

What is the FDA product code for UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK?

The FDA product code for UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK 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 Epcom Medical Systems, 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.

K910518GLOVE-N-GEL AMNIOTOMY KITK905812INTRAUTERINE CATHETER SETK881414CERVICATHK871079FETALFLEX FETAL ELECTRODEK8443381URO-LOG HOME DIAGNOSTIC PACKK841805OBSTETRICAL DOPPLER

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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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