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FDA 510(k)

COLOPLAST OSTOMY ROD, MODEL 12814

K-Number: K052229 · 2006-10-13

ApplicantColoplast Corp.
Decision Date2006-10-13
Product CodeEZP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLOPLAST OSTOMY ROD, MODEL 12814 is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2006-10-13 under 510(k) number K052229. The device is classified under product code EZP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLOPLAST OSTOMY ROD, MODEL 12814?

COLOPLAST OSTOMY ROD, MODEL 12814 is a medical device that received FDA 510(k) clearance on 2006-10-13. The listed applicant is Coloplast Corp.. The 510(k) number is K052229.

When did COLOPLAST OSTOMY ROD, MODEL 12814 receive FDA 510(k) clearance?

COLOPLAST OSTOMY ROD, MODEL 12814 received FDA 510(k) clearance on 2006-10-13, under 510(k) number K052229.

Who is the listed applicant for COLOPLAST OSTOMY ROD, MODEL 12814?

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

What is the FDA product code for COLOPLAST OSTOMY ROD, MODEL 12814?

The FDA product code for COLOPLAST OSTOMY ROD, MODEL 12814 is EZP.

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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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