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FDA 510(k)

UROFLOW-CYSTOMETER SYSTEM

K-Number: K771850 · 1977-10-18

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1977-10-18
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROFLOW-CYSTOMETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1977-10-18 under 510(k) number K771850. 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 UROFLOW-CYSTOMETER SYSTEM?

UROFLOW-CYSTOMETER SYSTEM is a medical device that received FDA 510(k) clearance on 1977-10-18. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K771850.

When did UROFLOW-CYSTOMETER SYSTEM receive FDA 510(k) clearance?

UROFLOW-CYSTOMETER SYSTEM received FDA 510(k) clearance on 1977-10-18, under 510(k) number K771850.

Who is the listed applicant for UROFLOW-CYSTOMETER SYSTEM?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROFLOW-CYSTOMETER SYSTEM?

The FDA product code for UROFLOW-CYSTOMETER SYSTEM is FAP.

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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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