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510(k) Data Aggregation
K Number
K152618Device Name
PANTHER Cutter Stapler
Manufacturer
Date Cleared
2015-11-12
(59 days)
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
B. J. ZH. F. PANTHER MEDICAL EQUIPMENT CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PANTHER Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.
Device Description
The proposed device, PANTHER Cutter Stapler, is sterilized and disposable surgical instruments, which is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
It delivers four staggered rows of titanium staples with a knife that divides the tissue simultaneously between the second and third row of staples. The PANTHER Cutter Stapler may be reloaded and fire no more than 6 times in a single procedure.
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