FDA 510(k)

THD Anopress with THD SensyProbe

K-Number: K180135 · 2018-03-08

Decision Date2018-03-08

Product CodeKLA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

THD Anopress with THD SensyProbe is the device name listed in this FDA 510(k) record. The listed applicant is Thd Spa. It received FDA 510(k) clearance on 2018-03-08 under 510(k) 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. The listed applicant is Thd Spa. The 510(k) number is K180135.

When did THD Anopress with THD SensyProbe receive FDA 510(k) clearance?

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

Who is the listed applicant for THD Anopress with THD SensyProbe?

The FDA 510(k) record lists Thd Spa as the applicant. This does not by itself establish the device manufacturer.

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 records listing Thd Spa as applicant

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.

K211623THD Procto Software System K193512THD Procto Software System K161785THD ANOPRESS

Related Devices (Code: KLA)

K242666Fecobionics Anorectal SystemGi Bionics, LLC K242304REDNeuraxis, Inc.K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp.K161785THD ANOPRESSThd Spa

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.