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)

LIFE-TECH #'S 1106/1156 UROLABS

K-Number: K812178 · 1981-08-13

ApplicantLife-Tech Instruments, Inc.
Decision Date1981-08-13
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LIFE-TECH #'S 1106/1156 UROLABS is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Instruments, Inc.. It received FDA 510(k) clearance on 1981-08-13 under 510(k) number K812178. 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 LIFE-TECH #'S 1106/1156 UROLABS?

LIFE-TECH #'S 1106/1156 UROLABS is a medical device that received FDA 510(k) clearance on 1981-08-13. The listed applicant is Life-Tech Instruments, Inc.. The 510(k) number is K812178.

When did LIFE-TECH #'S 1106/1156 UROLABS receive FDA 510(k) clearance?

LIFE-TECH #'S 1106/1156 UROLABS received FDA 510(k) clearance on 1981-08-13, under 510(k) number K812178.

Who is the listed applicant for LIFE-TECH #'S 1106/1156 UROLABS?

The FDA 510(k) record lists Life-Tech Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFE-TECH #'S 1106/1156 UROLABS?

The FDA product code for LIFE-TECH #'S 1106/1156 UROLABS 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 Life-Tech Instruments, 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.

K812177LIFE-TECH #1857 PRESSURE/POLOT MODULEK812179LIFE-TECH #1753 BIOFEEDBACK TRAINERK812180LIFE-TECH #5102 VISULABK800112AMBLYOPIA TRAINERK790663MODEL 1750 STANDING URINALK790664MODEL 1309 AUDIO MONITOR

View all 19 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.

↑