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FDA 510(k)

THD Procto Software System

K-Number: K211623 · 2021-06-24

ApplicantThd Spa
Decision Date2021-06-24
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THD Procto Software System is a medical device manufactured by Thd Spa. It received FDA 510(k) clearance on 2021-06-24 under approval number K211623. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THD Procto Software System?

THD Procto Software System is a medical device that received FDA 510(k) clearance on 2021-06-24. It is manufactured by Thd Spa. The 510(k) number is K211623.

When was THD Procto Software System approved by the FDA?

THD Procto Software System received FDA 510(k) clearance on 2021-06-24, under approval number K211623.

What company makes THD Procto Software System?

THD Procto Software System is manufactured by Thd Spa.

What is the FDA product code for THD Procto Software System?

The FDA product code for THD Procto Software System is IYO.

Related Clinical Trials

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 40845310 Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification? JMIR mHealth and uHealth (2025)

Other Devices by Thd Spa

K161785THD ANOPRESS K180135THD Anopress with THD SensyProbe K193512THD Procto Software System

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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.

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