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510(k) Data Aggregation
K Number
K252211Device Name
Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)
Manufacturer
Date Cleared
2025-08-11
(27 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CnC Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K220996Device Name
Duoblade
Manufacturer
Date Cleared
2023-02-03
(305 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CnC Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Duoblade is intended for general electrosurgical applications, including cutting and coagulation, and (Models: DB1SEP, DB1SEP-H, DB1SEP-T, DB1SEP-TH) for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Device Description
The Electrosurgical Cutting and Coagulation Device and Accessories (Model: Duoblade) is a single-use, monopolar RF device. It is designed to be used with the qualified Generator as part of the Surgery System. It can be operated with the integrated hand switch or a qualified Footswitch. The Duoblade consists of a single blade and telescoping shaft that can be configured in both standard and extended length. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids.
The models of of Duoblade are identified according to with/without a suction function (removing smoke).
- Suction function (Removing smoke): DB1SEP, DB1SEP-H, DB1SEP-T, DB1SEP-TH
- No Suction function (No removing smoke): DB1SP, DB1SP-H, DB1SP-T, DB1SP-TH
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