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 a medical device manufactured by Zhejiang Horizon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-22 under approval 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. It is manufactured by Zhejiang Horizon Medical Technology Co., Ltd.. The 510(k) number is K232163.

When was Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle approved by the FDA?

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

What company makes 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 manufactured by Zhejiang Horizon Medical Technology Co., Ltd..

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.

Related Clinical Trials

NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING NCT02299102 Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration Procedures COMPLETED NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT07240818 Comparison of FNB to EUS-CNB for Pancreatic Lesions NOT_YET_RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07571954 Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Zhejiang Horizon Medical Technology Co., Ltd.

K223265CryoX Vitrification Freeze Kit / Thaw Kit

Related Devices (Code: MQE)

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Official Source

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