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510(k) K023930

COOPERSURGICAL OOCYTE RECOVERY NEEDLES by CooperSurgical, Inc. — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2003
Date Received
November 25, 2002
Clearance Type
Traditional
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

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Other clearances for product code MQE

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  • 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)
  • 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)