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Sydney IVF Gamete Buffer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K153478

by William A. Cook Australia Pty. Ltd.

Identifiers

510(k) Number
K153478 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)

The Sydney IVF Gamete Buffer is a Media, Reproductive device designed for the physical washing and storage of gametes (sperm or egg cells) during in vitro fertilization (IVF) procedures. It provides a controlled environment to prepare gametes for fertilization by maintaining optimal conditions for viability and motility prior to the fertilization step.

This device is supplied as a sterile, single-use product intended for use in clinical fertility settings. It is classified as a Class II medical device under FDA regulations (884.6180) and has received FDA 510(k) clearance under the Traditional pathway. The Gamete Buffer is available in the model reference K-SIGB-20-AA and is not currently in commercial distribution as of the latest regulatory records.

Frequently asked questions

What is the Sydney IVF Gamete Buffer used for in clinical fertility procedures?

The Sydney IVF Gamete Buffer is designed specifically for washing and storing gametes—sperm or egg cells—during in vitro fertilization (IVF) procedures. It creates a controlled environment to maintain optimal conditions for viability and motility of the gametes before fertilization, ensuring they remain suitable for the next steps in the IVF process.

Is the Sydney IVF Gamete Buffer intended for single-use or repeated use?

The Sydney IVF Gamete Buffer is explicitly supplied as a sterile, single-use product. This design ensures patient safety and hygiene by preventing cross-contamination between procedures, which is critical in clinical fertility settings where sterility is paramount.

What model reference should I look for when ordering the Sydney IVF Gamete Buffer?

The Sydney IVF Gamete Buffer is available under the model reference K-SIGB-20-AA. This is the only listed model reference in the regulatory records, so confirming this reference with the manufacturer is important to ensure you receive the correct product.

How is the Sydney IVF Gamete Buffer stored, and are there any special handling requirements?

While the data does not specify storage conditions, the device is sterile and single-use, so it should be stored in a clean, dry environment protected from contamination and extreme temperatures. Always follow the manufacturer’s instructions for unopened packaging to maintain sterility until use.

What regulatory pathway was used for FDA clearance of the Sydney IVF Gamete Buffer?

The Sydney IVF Gamete Buffer received FDA 510(k) clearance under the Traditional pathway, meaning its safety and effectiveness were compared to a legally marketed predicate device. The clearance was granted on August 15, 2016, and the device is classified as a Class II medical device under FDA regulations (884.6180).

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 IVF Gamete Buffer (K153478) — FDA 510 (k) | Innolitics, Sydney, Australia | Official Sydney Tourism Website, SYDNEY IVF, GAMETE BUFFER Medical Device Identification, Sydney – Wikipedia, Sydney IVF - BEUDAMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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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) K153478 24 fields · synced Sep 19, 2026