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FDA 510(k)

THD Anopress with THD SensyProbe

K-Number: K180135 · 2018-03-08

ApplicantThd Spa
Decision Date2018-03-08
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THD Anopress with THD SensyProbe is a medical device manufactured by Thd Spa. It received FDA 510(k) clearance on 2018-03-08 under approval number K180135. 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 with THD SensyProbe?

THD Anopress with THD SensyProbe is a medical device that received FDA 510(k) clearance on 2018-03-08. It is manufactured by Thd Spa. The 510(k) number is K180135.

When was THD Anopress with THD SensyProbe approved by the FDA?

THD Anopress with THD SensyProbe received FDA 510(k) clearance on 2018-03-08, under approval number K180135.

What company makes THD Anopress with THD SensyProbe?

THD Anopress with THD SensyProbe is manufactured by Thd Spa.

What is the FDA product code for THD Anopress with THD SensyProbe?

The FDA product code for THD Anopress with THD SensyProbe is KLA.

Other Devices by Thd Spa

K161785THD ANOPRESS K193512THD Procto Software System K211623THD Procto Software System

Related Devices (Code: KLA)

K161785THD ANOPRESSThd 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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