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FDA 510(k)

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle

K-Number: K232163 · 2024-02-22

ApplicantZhejiang Horizon Medical Technology Co., Ltd.
Decision Date2024-02-22
Product CodeMQE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Horizon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K232163. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle?

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Zhejiang Horizon Medical Technology Co., Ltd.. The 510(k) number is K232163.

When did Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle receive FDA 510(k) clearance?

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle received FDA 510(k) clearance on 2024-02-22, under 510(k) number K232163.

Who is the listed applicant for Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle?

The FDA 510(k) record lists Zhejiang Horizon Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle?

The FDA product code for Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle is MQE.

Other records listing Zhejiang Horizon Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MQE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253121Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval NeedleGimbo Medical Technology Shenzhen Co., Ltd.K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)Shenzhen Vitavitro Biotech Co., Ltd.K190590Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)Allwin Medical Devices, Inc.K191291Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.K171625Single Lumen Ovum Aspiration NeedlesWillian A. Cook Australia Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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