Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF C…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153290 FDA 510(k)
- FDA Product Code
- MQL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6180 FDA 510(k)
- Regulation Number
- 884.6180 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a series of reproductive media used in IVF laboratories, comprising follicle flush buffer, fertilization medium, cleavage medium, and blastocyst medium. It is intended for use during in vitro fertilization procedures for processing eggs and embryos, including extended culture and transfer of embryos.
The device is supplied as a set of culture media for use in assisted reproductive technology settings. It is authorized under FDA 510(k) clearance (K153290) and classified as a Class II medical device under regulation number 884.6180, with product code MQL. The media are used in laboratory environments for handling and culturing human gametes and embryos during IVF procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sydney – Wikipedia, Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium ..., Sydney, Australia | Official Sydney Tourism Website, PDF 510_k_ Summary_Egg Embryo_v2_gp_10Nov2015, Cook® Sydney IVF Follicle Flush Buffer - Obex Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153290 | Class II | Active |
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Manufacturer
- Manufacturer
- William A. Cook Australia Pty. Ltd.
- FDA Applicant
- William A. Cook Australia Pty. , Ltd.
Sources (1)
- FDA 510(k) K153290 24 fields · synced Sep 22, 2026