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510(k) Data Aggregation
K Number
K222828Device Name
Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
Date Cleared
2023-03-20
(182 days)
Product Code
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 AuthorizedThirdparty
Intended Use
The Specimen Bag is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.
Device Description
The Specimen Bag is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Specimen Bag is supplied in a dispending tube for ease of insertion through a standard 10,11or 12mm trocar sheath.
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K Number
K172794Device Name
Suction Irrigation Set
Date Cleared
2017-11-29
(75 days)
Product Code
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 AuthorizedThirdparty
Intended Use
The Suction Irrigation Set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Device Description
The Suction Irrigation Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris from the surgical site.
The suction irrigation set consists of a hand piece equipped with two trumpet style valves,a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
The hand piece of the suction irrigation is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.
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