Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

URODYNAMICS TUBING KITS #5161, #5150, #7170

K-Number: K923995 · 1993-04-08

ApplicantAdvanced Medical Products, Inc.
Decision Date1993-04-08
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URODYNAMICS TUBING KITS #5161, #5150, #7170 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Products, Inc.. It received FDA 510(k) clearance on 1993-04-08 under 510(k) number K923995. 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 URODYNAMICS TUBING KITS #5161, #5150, #7170?

URODYNAMICS TUBING KITS #5161, #5150, #7170 is a medical device that received FDA 510(k) clearance on 1993-04-08. The listed applicant is Advanced Medical Products, Inc.. The 510(k) number is K923995.

When did URODYNAMICS TUBING KITS #5161, #5150, #7170 receive FDA 510(k) clearance?

URODYNAMICS TUBING KITS #5161, #5150, #7170 received FDA 510(k) clearance on 1993-04-08, under 510(k) number K923995.

Who is the listed applicant for URODYNAMICS TUBING KITS #5161, #5150, #7170?

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

What is the FDA product code for URODYNAMICS TUBING KITS #5161, #5150, #7170?

The FDA product code for URODYNAMICS TUBING KITS #5161, #5150, #7170 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 Advanced Medical Products, 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.

K000932ARACHNOPHLEBECTOMY NEEDLEK921426ULTRA PCIK912925ULTRA PVDK915658SPECTRA ECGK896103MICRO FL 7400 AMBULATORY HOLTER/BP MONITORK896102MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR

View all 14 devices →

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.

↑