Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
FDA 510(k) K151018 · Cook Incorporated
510(k) numberK151018
Submission
- Device name
- Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- April 16, 2015
- Decision date
- January 8, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQH – Microtools, Assisted Reproduction (Pipettes)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6130
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette cleared by the FDA?
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette (K151018) received a 510(k) decision of Substantially Equivalent on January 8, 2016, 267 days after the submission was received.
What is the product code of K151018?
The FDA product code is MQH – Microtools, Assisted Reproduction (Pipettes), a Class II (moderate risk) device regulated under 21 CFR 884.6130.