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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 a medical device manufactured by Coloplast A/S. It received FDA 510(k) clearance on 2018-02-12 under approval 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. It is manufactured by Coloplast A/S. The 510(k) number is K173527.

When was Digitex Delivery Device approved by the FDA?

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

What company makes Digitex Delivery Device?

Digitex Delivery Device is manufactured by Coloplast A/S.

What is the FDA product code for Digitex Delivery Device?

The FDA product code for Digitex Delivery Device is PWI.

Related Clinical Trials

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Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 40553217 Device reps in theatre: blurred boundaries or regulatory gaps? Monash bioethics review (2025) PMID: 39855465 [Review of practices concerning the delivery of an international implant card following the implantation of a medical device]. Annales pharmaceutiques francaises (2025)

Other Devices by Coloplast A/S

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Related Devices (Code: PWI)

K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation

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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