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510(k) Data Aggregation
K Number
K232163Device Name
Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
Manufacturer
Zhejiang Horizon Medical Technology Co., Ltd.
Date Cleared
2024-02-22
(216 days)
Product Code
MQE
Regulation Number
884.6100Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Horizon Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Lotus Single Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
Lotus Double Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
Device Description
The subject devices are single use sterile devices used for ultrasound-guided transvaginal aspiration of oocytes from ovarian follicles.
The Lotus Single Lumen Ovum Aspiration Needle consists of a stainless steel needle with a handle, which is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper is connected to a vacuum tube with a vacuum tubing connector at the other end. The vacuum tubing connector is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The Lotus Single Lumen Ovum Aspiration Needle is 35 cm in length and has device variations from 21 to 16 gauge with aspiration tubing of 600 or 900 mm in length.
The Lotus Double Lumen Ovum Aspiration Needle consists of a stainless steel needle with a Y shaped handle. The Y-shaped handle has two ports: the central port through which oocytes are aspirated via the aspiration lumen, and a secondary side port to allow flushing of follicles via the flushing lumen. The central port is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper has a vacuum connector that is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The side port is connected to a flushing tube with a flushing connector at the other end, which is a standard luer lock connector that can be connected to a compatible syringe for flushing of follicles. The Lotus Double Lumen Ovum Aspiration Needle is 17 gauge with an aspiration tubing length of 900 mm and with device variations of 30 or 35 mm needle length and flushing tubing of 700 or 1000 mm in length.
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