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FDA 510(k)

UROPUMP* FLUID MANAGEMENT SYSTEM

K-Number: K894363 · 1989-08-11

ApplicantOrthoconcept, Inc.
Decision Date1989-08-11
Product CodeFDC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROPUMP* FLUID MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthoconcept, Inc.. It received FDA 510(k) clearance on 1989-08-11 under 510(k) number K894363. The device is classified under product code FDC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROPUMP* FLUID MANAGEMENT SYSTEM?

UROPUMP* FLUID MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1989-08-11. The listed applicant is Orthoconcept, Inc.. The 510(k) number is K894363.

When did UROPUMP* FLUID MANAGEMENT SYSTEM receive FDA 510(k) clearance?

UROPUMP* FLUID MANAGEMENT SYSTEM received FDA 510(k) clearance on 1989-08-11, under 510(k) number K894363.

Who is the listed applicant for UROPUMP* FLUID MANAGEMENT SYSTEM?

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

What is the FDA product code for UROPUMP* FLUID MANAGEMENT SYSTEM?

The FDA product code for UROPUMP* FLUID MANAGEMENT SYSTEM is FDC.

Related Clinical Trials

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Other records listing Orthoconcept, 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.

K925160ARTHRO FMS 4K910164ORTHOCONCEPT ARTHROSCOPIC PUMPK905785ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)K896196ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHARK895643MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEMK882469CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES

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Related Devices (Code: FDC)

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.

K021166ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BRAcmi-Circon CorporationK992141OLYMPUS WORKING ELEMENT FOR PROBESOlympus Winter & Ibe GmbHK991426MAHE INSTRUMENTSMahe Intl., Inc.K942626CONTINUOUS FLOW BIOPSY PROBEGm Engineering, Inc.K933962GM CONTINUOUS FLOW BIOPSY PROBEGm Engineering, Inc.K895643MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEMOrthoconcept, 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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