Cleared Traditional

Follicle Aspiration Set

K161970 · Vitrolife Sweden AB · Obstetrics & Gynecology
Jun 2017
Decision
331d
Days
Class 2
Risk

About This 510(k) Submission

K161970 is an FDA 510(k) clearance for the Follicle Aspiration Set, a Needle, Assisted Reproduction (Class II — Special Controls, product code MQE), submitted by Vitrolife Sweden AB (V?stra Fr?lunda, SE). The FDA issued a Cleared decision on June 14, 2017, 331 days after receiving the submission on July 18, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6100.

Submission Details

510(k) Number K161970 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2016
Decision Date June 14, 2017
Days to Decision 331 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQE — Needle, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6100

Similar Devices — MQE Needle, Assisted Reproduction

All 31
VitaVitro? Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro? Double Lumen Oocyte Retrieval Needle (ORND-17G)
K240523 · Shenzhen Vitavitro Biotech Co., Ltd. · Nov 2024
Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
K232163 · Zhejiang Horizon Medical Technology Co., Ltd. · Feb 2024
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)
K190590 · Allwin Medical Devices, Inc. · Nov 2019
Wallace Dual Lumen Oocyte Recovery System
K191291 · CooperSurgical, Inc. · Jun 2019
Wallace Dual Lumen Oocyte Recovery System
K182959 · CooperSurgical, Inc. · May 2019
Single Lumen Ovum Aspiration Needles
K171625 · Willian A. Cook Australia Pty, Ltd. · Jan 2018

More from Vitrolife Sweden AB

View all
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
K243373 · MQF · Jul 2025
Ultrasound Transducer Cover
K241662 · ITX · Aug 2024
Ultra RapidWarm? Blast
K240605 · MQL · Aug 2024
Gx-IVF, Gx-TL, Gx-MOPS PLUS
K202862 · MQL · May 2021
RapidVit? Oocyte, RapidWarm? Oocyte
K183486 · MQL · Jul 2019