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510(k) Data Aggregation
K Number
K172578Device Name
Equipment Pouch
Date Cleared
2017-12-07
(101 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 Equipment Pouch is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.
Device Description
The Equipment Pouch is a sterile and single-use specimencontainer designed for use in retrieving specimens during endoscopic surgery. The Equipment Pouch is supplied in a dispending tube for ease of insertion through a standard 10, 11, or 12mm trocar sheath.
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