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FDA 510(k)

IRRIGATION SYSTEM

K-Number: K840268 · 1984-04-05

ApplicantColoplast A/S
Decision Date1984-04-05
Product CodeEXD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 1984-04-05 under 510(k) number K840268. The device is classified under product code EXD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION SYSTEM?

IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1984-04-05. The listed applicant is Coloplast A/S. The 510(k) number is K840268.

When did IRRIGATION SYSTEM receive FDA 510(k) clearance?

IRRIGATION SYSTEM received FDA 510(k) clearance on 1984-04-05, under 510(k) number K840268.

Who is the listed applicant for IRRIGATION SYSTEM?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRRIGATION SYSTEM?

The FDA product code for IRRIGATION SYSTEM is EXD.

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Other records listing Coloplast A/S as applicant

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Related Devices (Code: EXD)

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.

K121833OSTOMY IRRIGATION SETColoplast A/SK914692URINARY DIVERSION EVACUATING CATHETERCook Urological, Inc.K904586PALEX IRRIGATION SETPalex Intl. SAK871791BLOXOM IRRIGATORI.B. Bloxom C/O Hogan & HartsonK832299VISI-FLOW IRRIGATORConvatec, A Division of E.R. Squibb & SonsK823274UNI-TIP COLOSTOMY IRRIGATION CONEHowmedica Corp.

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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