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510(k) K171625

Single Lumen Ovum Aspiration Needles by Willian A. Cook Australia Pty, Ltd. — Product Code MQE

K171625 is an FDA 510(k) premarket notification submitted by Willian A. Cook Australia Pty, Ltd. for the device "Single Lumen Ovum Aspiration Needles". The FDA issued a decision of Substantially Equivalent on January 12, 2018. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Willian A. Cook Australia Pty, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2018
Date Received
June 2, 2017
Clearance Type
Special
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 Willian A. Cook Australia Pty, Ltd.

  • K152682 — Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit (May 5, 2016)

Other clearances for product code MQE

  • K253121 — Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retr (June 15, 2026)
  • K240523 — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® (November 15, 2024)
  • K232163 — Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Ne (February 22, 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)
  • 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)

FDA data resources