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FDA 510(k)

THD ANOPRESS

K-Number: K161785 · 2017-03-14

ApplicantThd Spa
Decision Date2017-03-14
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THD ANOPRESS is a medical device manufactured by Thd Spa. It received FDA 510(k) clearance on 2017-03-14 under approval number K161785. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THD ANOPRESS?

THD ANOPRESS is a medical device that received FDA 510(k) clearance on 2017-03-14. It is manufactured by Thd Spa. The 510(k) number is K161785.

When was THD ANOPRESS approved by the FDA?

THD ANOPRESS received FDA 510(k) clearance on 2017-03-14, under approval number K161785.

What company makes THD ANOPRESS?

THD ANOPRESS is manufactured by Thd Spa.

What is the FDA product code for THD ANOPRESS?

The FDA product code for THD ANOPRESS is KLA.

Other Devices by Thd Spa

K180135THD Anopress with THD SensyProbe K193512THD Procto Software System K211623THD Procto Software System

Related Devices (Code: KLA)

K180135THD Anopress with THD SensyProbeThd Spa K242304REDNeuraxis, Inc. K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp. K242666Fecobionics Anorectal SystemGi Bionics, LLC

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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