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510(k) Data Aggregation
K Number
K150824Device Name
TD-Wand
Manufacturer
Date Cleared
2015-05-28
(57 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
TDM SURGITECH, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TDM SurgiTech TD-Wand is intended for use in procedures that require precise cuts where only light or no hemostasis is desired using the cut mode and procedures where a greater level of hemostasis is desired using the coag and blend modes.
Device Description
TDM SurgiTech, Inc. ("TDMi")'s TD-Wand is a sterile, single use, disposable, monopolar device for use only with IEC 60601-1 certified electrosurgical units ("ESUs") that accept 3-pinned connectors. The TD-Wand combines blunt dissection with electrosection and electrocoagulation at its ceramic tip. The ceramic tip's bulbs provide blunt dissection capabilities between tissue planes similar to a cannula, bulbous scissors, or other blunt instrument. As such, initiation of the dissection path may be facilitated with the use of traditional surgical instruments. The device employs two types of recessed stainless steel electrodes that distribute electrosurgical current:
(1) For cutting, the Cutting Electrode is comprised of 3 segments protectively recessed between four ceramic bulbs at the axial tip. When activated, the Cutting Electrode, along its 3 recessed segments, distributes a cut or blended cut/coag waveform yielding a cutting effect that may also have a hemostatic effect depending upon the "blended" waveform chosen.
(2) For coagulation, the Coagulation Electrode, via the 7 termini protectively recessed atop the ceramic domes in the chevron shape, distributes coagulation waveforms producing a disbursed surface coagulation effect.
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