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510(k) K221810

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device by Bonraybio Co., Ltd. — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2022
Date Received
June 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

Other clearances by Bonraybio Co., Ltd.

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  • K202089 — LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analy (October 28, 2020)
  • K180343 — LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer (November 16, 2018)

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  • K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (January 31, 2025)
  • K241341 — cryo-GO Vitrification Device (September 26, 2024)
  • K240002 — G-Vitri™ Vitrification Straw (June 14, 2024)
  • K232980 — SpermAlign Sperm Separation Device (March 14, 2024)
  • K233177 — Nest VT Vitrification Device (March 8, 2024)
  • K213869 — EmbryoSlide+ ic8 dish (March 11, 2022)
  • K203626 — SureStrip Vitrification Straw, SureLock Vitrification Straw (June 4, 2021)
  • K201213 — Pasteur Pipette 3mL, Pasteur Pipette 1mL (December 16, 2020)