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FDA 510(k)

Digitex Delivery Device

K-Number: K173527 · 2018-02-12

ApplicantColoplast A/S
Decision Date2018-02-12
Product CodePWI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Digitex Delivery Device 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 2018-02-12 under 510(k) number K173527. The device is classified under product code PWI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digitex Delivery Device?

Digitex Delivery Device is a medical device that received FDA 510(k) clearance on 2018-02-12. The listed applicant is Coloplast A/S. The 510(k) number is K173527.

When did Digitex Delivery Device receive FDA 510(k) clearance?

Digitex Delivery Device received FDA 510(k) clearance on 2018-02-12, under 510(k) number K173527.

Who is the listed applicant for Digitex Delivery Device?

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 Digitex Delivery Device?

The FDA product code for Digitex Delivery Device is PWI.

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Related Devices (Code: PWI)

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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