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FDA 510(k)

F.M. WEIST,KG (URODYNAMIC SYSTEMS)

K-Number: K860571 · 1986-03-18

ApplicantF.M. Wiest USA, Inc.
Decision Date1986-03-18
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

F.M. WEIST,KG (URODYNAMIC SYSTEMS) is the device name listed in this FDA 510(k) record. The listed applicant is F.M. Wiest USA, Inc.. It received FDA 510(k) clearance on 1986-03-18 under 510(k) number K860571. 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 F.M. WEIST,KG (URODYNAMIC SYSTEMS)?

F.M. WEIST,KG (URODYNAMIC SYSTEMS) is a medical device that received FDA 510(k) clearance on 1986-03-18. The listed applicant is F.M. Wiest USA, Inc.. The 510(k) number is K860571.

When did F.M. WEIST,KG (URODYNAMIC SYSTEMS) receive FDA 510(k) clearance?

F.M. WEIST,KG (URODYNAMIC SYSTEMS) received FDA 510(k) clearance on 1986-03-18, under 510(k) number K860571.

Who is the listed applicant for F.M. WEIST,KG (URODYNAMIC SYSTEMS)?

The FDA 510(k) record lists F.M. Wiest USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F.M. WEIST,KG (URODYNAMIC SYSTEMS)?

The FDA product code for F.M. WEIST,KG (URODYNAMIC SYSTEMS) 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 F.M. Wiest USA, 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.

K921871HYSTEROMAT(TM) 3700K920574CAMSYS 6300K920575MERKUR 4000K915751URETEROMAT 4400K911844HYSTEROFLATOR 1500K912071SPACE(TM) 7500

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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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