Home / 510(k) Clearances / K082727

510(k) K082727

FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN by Vitrolife Sweden AB — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2009
Date Received
September 17, 2008
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

Other clearances by Vitrolife Sweden AB

  • K243373 — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - (July 23, 2025)
  • K241662 — Ultrasound Transducer Cover (August 30, 2024)
  • K240605 — Ultra RapidWarm™ Blast (August 7, 2024)
  • K202862 — Gx-IVF, Gx-TL, Gx-MOPS PLUS (May 14, 2021)
  • K183486 — RapidVit™ Oocyte, RapidWarm™ Oocyte (July 26, 2019)
  • K181461 — Rapid-i™ Kit (January 4, 2019)
  • K172050 — Follicle Aspiration Set, Reduced Single Lumen (November 21, 2017)
  • K161970 — Follicle Aspiration Set (June 14, 2017)
  • K150950 — FreezeKit Cleave , ThawKit Cleave (December 21, 2015)
  • K140207 — RAPID-I KIT (December 18, 2014)

Other clearances for product code MQE

  • 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)
  • 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)