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FDA 510(k)

URITROL-M

K-Number: K842808 · 1984-11-16

ApplicantThe Washington Group, Inc.
Decision Date1984-11-16
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URITROL-M is the device name listed in this FDA 510(k) record. The listed applicant is The Washington Group, Inc.. It received FDA 510(k) clearance on 1984-11-16 under 510(k) number K842808. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URITROL-M?

URITROL-M is a medical device that received FDA 510(k) clearance on 1984-11-16. The listed applicant is The Washington Group, Inc.. The 510(k) number is K842808.

When did URITROL-M receive FDA 510(k) clearance?

URITROL-M received FDA 510(k) clearance on 1984-11-16, under 510(k) number K842808.

Who is the listed applicant for URITROL-M?

The FDA 510(k) record lists The Washington Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URITROL-M?

The FDA product code for URITROL-M is KNT.

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Related Devices (Code: KNT)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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