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510(k) Data Aggregation
K Number
K241022Device Name
Sterile single use tip cleaner (WK800-S10 , WK800-S20)
Manufacturer
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
Date Cleared
2024-07-11
(87 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The sterile single use 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 product has 2 sizes: 50mm(L)×50mm(W)×5mm(T) and 50mm(L)×25mm(W)× 5mm(T). The product is composed by a 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 base and pressure sensitive 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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K Number
K172038Device Name
Trocar
Manufacturer
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd.
Date Cleared
2017-10-27
(114 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trocar, Model: Auto-Locking Trocar, Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Trocar Models: Auto-Locking Trocar, Bladeless Trocar and Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
Device Description
The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three kinds of diameter sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. Auto-Locking Trocar 10 mm can accept 4 mm to 11 mm sized instruments with its built-in universal seal without the use of a converter. Auto-Locking Trocar 12 mm can accept 4 mm to 13 mm sized instruments with its built-in universal seal without the use of a converter.
The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock.
The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip,, which is designed for open Laparoscopy. The visible trocar is available in three sizes: 5mm, 10mm and 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock.
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K Number
K172120Device Name
Veress Needle
Manufacturer
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd.
Date Cleared
2017-09-14
(63 days)
Product Code
FHO, HIF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Device Description
The Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
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