FDA 510(k)

SPEEDICATH COMPACT SET (12/18 FR)

K-Number: K121458 · 2012-10-01

Decision Date2012-10-01

Product CodeGBM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SPEEDICATH COMPACT SET (12/18 FR) 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 2012-10-01 under 510(k) number K121458. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEEDICATH COMPACT SET (12/18 FR)?

SPEEDICATH COMPACT SET (12/18 FR) is a medical device that received FDA 510(k) clearance on 2012-10-01. The listed applicant is Coloplast A/S. The 510(k) number is K121458.

When did SPEEDICATH COMPACT SET (12/18 FR) receive FDA 510(k) clearance?

SPEEDICATH COMPACT SET (12/18 FR) received FDA 510(k) clearance on 2012-10-01, under 510(k) number K121458.

Who is the listed applicant for SPEEDICATH COMPACT SET (12/18 FR)?

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 SPEEDICATH COMPACT SET (12/18 FR)?

The FDA product code for SPEEDICATH COMPACT SET (12/18 FR) is GBM.

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Related Devices (Code: GBM)

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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.