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Data / Medical devices / Italy / THD SPA

THD SPA: FDA-registered device maker in Correggio Reggio Emilia, Italy, 16 510(k) clearances

THD SPA is registered with the FDA (registration 3006680097) in Correggio Reggio Emilia, Italy. It lists 18 device types. The FDA files 16 510(k) clearances under its listings, the newest dated June 24, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3006680097
Address
Via per Carpi, 15/B, Correggio Reggio Emilia, Italy, 42015
Owner or operator
THD SpA (10025818)
Roles
Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
May 12, 2008
Registered through
2026
Brand names listed
Daisy, Maestro, HRA Camera 2, Inflation Bulb, MediCam Plus, THD 4K CAM, THD ANOLIFT US, THD ANOPRESS, THD BIOPSY (GI - XL) and more

Devices it lists

DeviceProduct codeClassRoleSource
Anoscope And AccessoriesFER2Manufactureraccessdata.fda.gov
Bulb, Inflation, For EndoscopeFCY1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Camera, Television, Endoscopic, With AudioFWG1Exporter to the US, Manufactureraccessdata.fda.gov
Camera, Television, Endoscopic, Without AudioFWF1Manufactureraccessdata.fda.gov
Endoscope, Ac-Powered And AccessoriesGCP2Manufactureraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Manufactureraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Manufactureraccessdata.fda.gov
Medical Device Data SystemOUG1Exporter to the US, Manufactureraccessdata.fda.gov
Monitor, Esophageal Motility, Anorectal Motility, And TubeKLA2Manufactureraccessdata.fda.gov
Monitor, Ultrasonic, NonfetalJAF2Manufactureraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Exporter to the USaccessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional OutputONG2Exporter to the USaccessdata.fda.gov
ProctoscopeGCF2Manufactureraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Exporter to the USaccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Exporter to the USaccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Exporter to the USaccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Exporter to the US, Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Exporter to the US, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 24, 2021K211623THD Procto Software SystemIYOSubstantially EquivalentThd Spaaccessdata.fda.gov
March 8, 2018K180135THD Anopress with THD SensyProbeKLASubstantially EquivalentThd Spaaccessdata.fda.gov
April 13, 2017K163443Interson USB Ultrasound SystemIYNSubstantially EquivalentInterson Corporationaccessdata.fda.gov
March 14, 2017K161785THD ANOPRESSKLASubstantially EquivalentThd Spaaccessdata.fda.gov
May 19, 2016K150553FilblocNEWSubstantially EquivalentAssut Europeaccessdata.fda.gov
February 24, 2015K141657THD REVOLUTIONJAFSubstantially EquivalentThd Spaaccessdata.fda.gov
December 11, 2013K133687THD N-ANO ANOSCOPEFERSubstantially EquivalentThd Spaaccessdata.fda.gov
June 1, 2012K121135THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPEFERSubstantially EquivalentThd Spaaccessdata.fda.gov
July 22, 2011K110984SLIM E30 II CO2 LASERONGSubstantially EquivalentLasering S.R.L.accessdata.fda.gov
March 1, 2011K103647THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPESFERSubstantially EquivalentThd Spaaccessdata.fda.gov
July 15, 2010K093497THD BANDYFHNSubstantially EquivalentThd Spaaccessdata.fda.gov
June 11, 2009K091490FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPESFERSubstantially EquivalentThd Spaaccessdata.fda.gov
January 28, 2009K090009THD SLIDE ONEJAFSubstantially EquivalentThd Spaaccessdata.fda.gov
July 30, 2008K081429THD SLIDEJAFSubstantially EquivalentThd Spaaccessdata.fda.gov
April 9, 2008K080132THD DISPOSABLE ANOSCOPE/PROCTOSCOPEFERSubstantially EquivalentThd Spaaccessdata.fda.gov
April 8, 2005K041515TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTUREGAMSubstantially EquivalentSutures India Private Limitedaccessdata.fda.gov

Compare with other makers

Updated June 24, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.