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FDA 510(k)

Single Lumen Ovum Aspiration Needles

K-Number: K171625 · 2018-01-12

ApplicantWillian A. Cook Australia Pty, Ltd.
Decision Date2018-01-12
Product CodeMQE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Single Lumen Ovum Aspiration Needles is a medical device manufactured by Willian A. Cook Australia Pty, Ltd.. It received FDA 510(k) clearance on 2018-01-12 under approval number K171625. 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 Single Lumen Ovum Aspiration Needles?

Single Lumen Ovum Aspiration Needles is a medical device that received FDA 510(k) clearance on 2018-01-12. It is manufactured by Willian A. Cook Australia Pty, Ltd.. The 510(k) number is K171625.

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

Single Lumen Ovum Aspiration Needles received FDA 510(k) clearance on 2018-01-12, under approval number K171625.

What company makes Single Lumen Ovum Aspiration Needles?

Single Lumen Ovum Aspiration Needles is manufactured by Willian A. Cook Australia Pty, Ltd..

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

The FDA product code for Single 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 NCT02299102 Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration Procedures COMPLETED NCT06741657 A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways COMPLETED NCT07571954 Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy NOT_YET_RECRUITING NCT07566039 Cohort Study of PPP Injections for Athletes With Muscle Injury NOT_YET_RECRUITING NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING

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

K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

Related Devices (Code: MQE)

K171611Double Lumen Ovum Aspiration NeedlesWilliam A. Cook Australia Pty. , Ltd. K172050Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB K162881Kitazato OPU NeedlesKitazato Corporation K161970Follicle Aspiration SetVitrolife Sweden AB 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.

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