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FDA 510(k)

PROCON2

K-Number: K042431 · 2005-05-27

ApplicantIncontinent Control Devices, Inc.
Decision Date2005-05-27
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PROCON2 is the device name listed in this FDA 510(k) record. The listed applicant is Incontinent Control Devices, Inc.. It received FDA 510(k) clearance on 2005-05-27 under 510(k) number K042431. 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 PROCON2?

PROCON2 is a medical device that received FDA 510(k) clearance on 2005-05-27. The listed applicant is Incontinent Control Devices, Inc.. The 510(k) number is K042431.

When did PROCON2 receive FDA 510(k) clearance?

PROCON2 received FDA 510(k) clearance on 2005-05-27, under 510(k) number K042431.

Who is the listed applicant for PROCON2?

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

What is the FDA product code for PROCON2?

The FDA product code for PROCON2 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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