Cleared Traditional

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

K221810 · Bonraybio Co., Ltd. · Obstetrics & Gynecology
Oct 2022
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K221810 is an FDA 510(k) clearance for the LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device, a Labware, Assisted Reproduction (Class II — Special Controls, product code MQK), submitted by Bonraybio Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on October 31, 2022, 131 days after receiving the submission on June 22, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6160.

Submission Details

510(k) Number K221810 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2022
Decision Date October 31, 2022
Days to Decision 131 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQK — Labware, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6160

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