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510(k) Data Aggregation
K Number
K233002Device Name
BEED 2,5, BEED 3,8
Manufacturer
Date Cleared
2024-03-20
(180 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Excelsior Resources LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BEED 3,8 and BEED 2,5 device are used for electrosurgical cutting and coagulation through tissues, or within tissue planes while maintaining hemostasis.
Device Description
The BEED device is available in two configurations as BEED-2,5 or BEED-3,8 and is a monopolar, Bead-Enhanced Electrosurgical Dissector (BEED) that dissects and separates tissue planes using both forward and backward strokes. Distal facing beads and lysing segments enable forward dissection. The proximal facing bead and lysing segment allow for rearward dissection.
BEED operates when connected to a compatible electrosurgical unit (ESU) via a universal 4mm monopolar connector cable, and a neutral electrode that shall be used with the ESU. The compatible ESU supplies current and voltage to the device and is typically controlled via a footswitch. The power supplied to the BEED device can range from 20- 50 Watts, depending on user preference.
The BEED-2.5 model consists of two bead-like structures, two RF electrified (monopolar) cutting edges protectively recessed between two non-conductive ceramic protrusions on the distal end and measures 5mm in width and may be preferred for smaller cuts. Whereas the BEED-3,8 model is larger and consists of three bead-like structures and three RF electrified (monopolar) cutting edges protectively recessed within three non-conductive ceramic protrusions on the distal end and measures 8mm in width.
Each BEED model is provided with a clamp-on, adjustable plastic handle that can lock along various lengths of the shaft.
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