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510(k) Data Aggregation
K Number
K982287Device Name
ASLAN SENSOR MODULAR INSTRUMENT
Manufacturer
Date Cleared
1998-08-06
(37 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ASLAN MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Aslan Modular Instruments are intended to be used by a qualified surgeon for grasping, manipulating, cutting and/or coagulating tissue in endoscopic (videoscopic) procedures.
Device Description
Aslan Modular Instruments comprise a modular line of re-usable instruments consisting of various size shafts, handles of various configurations, and a number of interchangeable tips which can be used in laparoscopic surgery for grasping, cutting, and cauterizing delicate tissues using monopolar electrocautery. The tips and shafts, sized to fit through 5mm, 10mm or 12mm cannulae, range in length from 12cm to 45cm. For ease of cleaning, the tip, together with its actuating rod, can be completely removed from the shaft, and the tip-and-shaft assembly may be completely removed from the handle.
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K Number
K954864Device Name
ASLAN MODULAR INSTRUMENT
Manufacturer
Date Cleared
1996-02-09
(109 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ASLAN MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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