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510(k) Data Aggregation
K Number
K070815Device Name
THD
Manufacturer
G.F. S.R.L.
Date Cleared
2007-06-20
(86 days)
Product Code
JAF
Regulation Number
892.1540Why did this record match?
Applicant Name (Manufacturer) :
G.F. S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The THD Evolution Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler systems, placed inside the THD Evolution device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a proctoscope, sutures and superior holder included in the THD Kit.
The THD is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.
Device Description
The THD consists of the THD Evolution Doppler Device and the THD Kit. The THD Evolution Doppler is a 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler must be used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation.
The THD Kit is a sterilized surgical kit comprised of a proctoscope, sutures, a needle holder and a knot tightener.
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