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FDA 510(k)

MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM

K-Number: K895643 · 1989-10-17

ApplicantOrthoconcept, Inc.
Decision Date1989-10-17
Product CodeFDC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED 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 1989-10-17 under 510(k) number K895643. 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 MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM?

MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Orthoconcept, Inc.. The 510(k) number is K895643.

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

MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM received FDA 510(k) clearance on 1989-10-17, under 510(k) number K895643.

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

The FDA product code for MODIFIED 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, RECHARK894363UROPUMP* 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.K894363UROPUMP* 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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