Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle— 510(k) K232163
Substantially EquivalentZhejiang Horizon Medical Technology Co., Ltd.
FDA 510(k) clearance K232163 for Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle, Substantially Equivalent on 2024-02-22. Applicant: Zhejiang Horizon Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhejiang Horizon Medical Technology Co., Ltd.
- Product code
- Code MQE
- Device class
- Class 2
- Regulation
- 21 CFR 884.6100
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jiaxing, CN
Recent devices under product code MQE
view all- K253121 — Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle
- K240523 — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
- K190590 — Allwin 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)
- K191291 — Wallace Dual Lumen Oocyte Recovery System
- K182959 — Wallace Dual Lumen Oocyte Recovery System
More clearances from Zhejiang Horizon Medical Technology Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.