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FDA 510(k)

UNI-TIP COLOSTOMY IRRIGATION CONE

K-Number: K823274 · 1982-12-07

ApplicantHowmedica Corp.
Decision Date1982-12-07
Product CodeEXD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNI-TIP COLOSTOMY IRRIGATION CONE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1982-12-07 under 510(k) number K823274. 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 UNI-TIP COLOSTOMY IRRIGATION CONE?

UNI-TIP COLOSTOMY IRRIGATION CONE is a medical device that received FDA 510(k) clearance on 1982-12-07. The listed applicant is Howmedica Corp.. The 510(k) number is K823274.

When did UNI-TIP COLOSTOMY IRRIGATION CONE receive FDA 510(k) clearance?

UNI-TIP COLOSTOMY IRRIGATION CONE received FDA 510(k) clearance on 1982-12-07, under 510(k) number K823274.

Who is the listed applicant for UNI-TIP COLOSTOMY IRRIGATION CONE?

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

What is the FDA product code for UNI-TIP COLOSTOMY IRRIGATION CONE?

The FDA product code for UNI-TIP COLOSTOMY IRRIGATION CONE is EXD.

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Other records listing Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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 & HartsonK840268IRRIGATION SYSTEMColoplast A/SK832299VISI-FLOW IRRIGATORConvatec, A Division of E.R. Squibb & Sons

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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