Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette— 510(k) K151018

Name: FDA 510(k) clearance K151018
Creator: U.S. Food and Drug Administration
Published: 2016-01-08

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K151018 for Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette, Substantially Equivalent on 2016-01-08. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code MQH
Device class: Class 2
Regulation: 21 CFR 884.6130
Advisory panel: Obstetrics/Gynecology
Date received: 2015-04-16
Decision date: 2016-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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