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510(k) K171611

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

K171611 is an FDA 510(k) premarket notification submitted by William A. Cook Australia Pty. , Ltd. for the device "Double Lumen Ovum Aspiration Needles". The FDA issued a decision of Substantially Equivalent on December 15, 2017. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. William A. Cook Australia Pty. , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2017
Date Received
June 1, 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 William A. Cook Australia Pty. , Ltd.

  • K173431 — Towako Transmyometrial Embryo Transfer Set (May 18, 2018)
  • K160753 — COOK Vacuum Pump (June 13, 2017)
  • K170257 — Sydney IVF Culture Oil (February 24, 2017)
  • K153478 — Sydney IVF Gamete Buffer (August 15, 2016)
  • K152717 — Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit (May 6, 2016)
  • K160814 — Sydney IVF Sperm Cryopreservation Buffer (April 22, 2016)
  • K151367 — Sydney IVF Hyaluronidase (January 27, 2016)
  • K153290 — Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cl (January 27, 2016)
  • K152782 — SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT (December 21, 2015)
  • K152904 — SYDNEY IVF EMBRYO BIOPSY MEDIUM (December 3, 2015)

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)
  • K171625 — Single Lumen Ovum Aspiration Needles (January 12, 2018)
  • 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