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FDA 510(k)

MERKUR 4000

K-Number: K920575 · 1992-07-23

ApplicantF.M. Wiest USA, Inc.
Decision Date1992-07-23
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MERKUR 4000 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 1992-07-23 under 510(k) number K920575. 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 MERKUR 4000?

MERKUR 4000 is a medical device that received FDA 510(k) clearance on 1992-07-23. The listed applicant is F.M. Wiest USA, Inc.. The 510(k) number is K920575.

When did MERKUR 4000 receive FDA 510(k) clearance?

MERKUR 4000 received FDA 510(k) clearance on 1992-07-23, under 510(k) number K920575.

Who is the listed applicant for MERKUR 4000?

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 MERKUR 4000?

The FDA product code for MERKUR 4000 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 6300K915751URETEROMAT 4400K911844HYSTEROFLATOR 1500K912071SPACE(TM) 7500K910883LAPAROFLATOR ELECTRONIC 3509

View all 12 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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