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510(k) K232163

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle by Zhejiang Horizon Medical Technology Co., Ltd. — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2024
Date Received
July 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6100
Review Panel
OB
Submission Type

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

  • K223265 — CryoX Vitrification Freeze Kit / Thaw Kit (May 11, 2023)

Other clearances for product code MQE

  • K240523 — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® (November 15, 2024)
  • K190590 — Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double (November 25, 2019)
  • K191291 — Wallace Dual Lumen Oocyte Recovery System (June 12, 2019)
  • K182959 — Wallace Dual Lumen Oocyte Recovery System (May 10, 2019)
  • K171625 — Single Lumen Ovum Aspiration Needles (January 12, 2018)
  • K171611 — Double Lumen Ovum Aspiration Needles (December 15, 2017)
  • K172050 — Follicle Aspiration Set, Reduced Single Lumen (November 21, 2017)
  • K162881 — Kitazato OPU Needles (July 11, 2017)
  • K161970 — Follicle Aspiration Set (June 14, 2017)
  • K141365 — OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN (August 7, 2014)