Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Double Lumen Ovum Aspiration Needles

K-Number: K171611 · 2017-12-15

ApplicantWilliam A. Cook Australia Pty. , Ltd.
Decision Date2017-12-15
Product CodeMQE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Double Lumen Ovum Aspiration Needles is a medical device manufactured by William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2017-12-15 under approval number K171611. 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 Double Lumen Ovum Aspiration Needles?

Double Lumen Ovum Aspiration Needles is a medical device that received FDA 510(k) clearance on 2017-12-15. It is manufactured by William A. Cook Australia Pty. , Ltd.. The 510(k) number is K171611.

When was Double Lumen Ovum Aspiration Needles approved by the FDA?

Double Lumen Ovum Aspiration Needles received FDA 510(k) clearance on 2017-12-15, under approval number K171611.

What company makes Double Lumen Ovum Aspiration Needles?

Double Lumen Ovum Aspiration Needles is manufactured by William A. Cook Australia Pty. , Ltd..

What is the FDA product code for Double Lumen Ovum Aspiration Needles?

The FDA product code for Double Lumen Ovum Aspiration Needles is MQE.

Related Clinical Trials

NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING NCT06375967 EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) SUSPENDED NCT07247721 Transcutaneous vs Percutaneous Electrical Stimulation of the Radial Nerve COMPLETED NCT07097584 Effect of Small Double-lumen Tube on the Intubation Time of Thoracoscopic Pulmonectomy in Asian Women COMPLETED

Other Devices by William A. Cook Australia Pty. , Ltd.

K153478Sydney IVF Gamete Buffer K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit K160814Sydney IVF Sperm Cryopreservation Buffer K151367Sydney IVF Hyaluronidase K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium K160753COOK Vacuum Pump

View all 9 devices →

Related Devices (Code: MQE)

K172050Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB K162881Kitazato OPU NeedlesKitazato Corporation K161970Follicle Aspiration SetVitrolife Sweden AB K171625Single Lumen Ovum Aspiration NeedlesWillian A. Cook Australia Pty, 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.

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.

↑