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510(k) Data Aggregation
K Number
K211197Device Name
Disposable Endoscopic Cutter Stapler and Cartridge
Manufacturer
Changzhou Waston Medical Appliance Co., Ltd
Date Cleared
2023-01-19
(638 days)
Product Code
GDW, GAG
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
Changzhou Waston Medical Appliance Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Endoscopic Cutter Stapler and Cartridge has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. The Disposable Endoscopic Cutter Stapler and Cartridge is not to be used in the transection and resection of solid organs.
Device Description
Disposable Endoscopic Cutter Stapler and Cartridge place two, triple-staggered rows of progressive titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths with cartridge in 2.0/2.5/3.0, 3.0/3.5/4.0, 4.0/4.5/5.0 three progressive staple sizes to accommodate carious tissue thickness. The device may be reloaded and fired up to 12 times in a single procedure.
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K Number
K151062Device Name
WASTON Metallic Intramedullary Nail System
Manufacturer
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD
Date Cleared
2015-12-17
(241 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Simple, compound first- and second-degree tibial shaft fractures
Pseudarthrosis and delayed union
Device Description
The WASTON Metallic Intramedullary Nail System is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments.
The intramedullary nail is available in a variety of lengths to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections.
All implants of Metallic Intramedullary Nail System are manufactured from Ti-6Al-4V alloy that meets the requirements of ASTM F-136.
The proposed devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.
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