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FDA 510(k)

CATHETER, URETHRAL PRESSURE, UPE-10 & 12

K-Number: K770579 · 1977-05-23

ApplicantLife-Tech Instruments, Inc.
Decision Date1977-05-23
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETER, URETHRAL PRESSURE, UPE-10 & 12 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 1977-05-23 under 510(k) number K770579. 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 CATHETER, URETHRAL PRESSURE, UPE-10 & 12?

CATHETER, URETHRAL PRESSURE, UPE-10 & 12 is a medical device that received FDA 510(k) clearance on 1977-05-23. The listed applicant is Life-Tech Instruments, Inc.. The 510(k) number is K770579.

When did CATHETER, URETHRAL PRESSURE, UPE-10 & 12 receive FDA 510(k) clearance?

CATHETER, URETHRAL PRESSURE, UPE-10 & 12 received FDA 510(k) clearance on 1977-05-23, under 510(k) number K770579.

Who is the listed applicant for CATHETER, URETHRAL PRESSURE, UPE-10 & 12?

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 CATHETER, URETHRAL PRESSURE, UPE-10 & 12?

The FDA product code for CATHETER, URETHRAL PRESSURE, UPE-10 & 12 is FAP.

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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 VISULABK812178LIFE-TECH #'S 1106/1156 UROLABSK800112AMBLYOPIA TRAINERK790663MODEL 1750 STANDING URINAL

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.

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