Flexipet Denuding Pipette, Flexipet Manipulation Pipette
FDA 510(k) K150748 · Cook Incorporated
510(k) numberK150748
Submission
- Device name
- Flexipet Denuding Pipette, Flexipet Manipulation Pipette
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- March 23, 2015
- Decision date
- December 18, 2015
- 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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| K192146 | V-DenupetMQH · Traditional | Vitromed GmbH | 01/28/2020SE |
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| K133257 | Biopsy PipettesMQH · Traditional | Research Instruments , Ltd. | 05/16/2014SE |
| K102480 | Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona…MQH · Traditional | Jieying Laboratory, Inc. | 04/19/2011SE |
| K092554 | Blastomere Biopsy Pipettes, Polar Body Biopsy PipettesMQH · Traditional | Sunlight Medical, Inc. | 04/30/2010SE |
| K072600 | Intracytoplasmic Sperm and Spermatid Injection, Holding, Zone Drilling, Partial Zone…MQH · Traditional | Sunlight Medical, Inc. | 05/19/2008SE |
| K041435 | The Stripper PGDMQH · Traditional | Mid-Atlantic Diagnostics, Inc. | 09/29/2004SE |
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Questions and answers
When was Flexipet Denuding Pipette, Flexipet Manipulation Pipette cleared by the FDA?
Flexipet Denuding Pipette, Flexipet Manipulation Pipette (K150748) received a 510(k) decision of Substantially Equivalent on December 18, 2015, 270 days after the submission was received.
What is the product code of K150748?
The FDA product code is MQH – Microtools, Assisted Reproduction (Pipettes), a Class II (moderate risk) device regulated under 21 CFR 884.6130.