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510(k) Data Aggregation
K Number
K150532Device Name
Universal Light Handle Cover, Light Handle Cover
Manufacturer
Key Surgical, Inc.
Date Cleared
2015-09-22
(204 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
Key Surgical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K151222Device Name
Cautery Tip Cleaner
Manufacturer
KEY SURGICAL, INC.
Date Cleared
2015-05-22
(15 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
KEY SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
Device Description
The disposable cautery tip cleaner is a 50mm by 50mm small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel', with a polyurethane foam pad and polyurethane adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.
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