Puresperm 40 and Puresperm 80
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K002623 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 Puresperm 40 and Puresperm 80 are semen processing media designed to separate sperm from seminal plasma through density gradient centrifugation. These devices facilitate the isolation of motile sperm for assisted reproductive techniques, enabling improved selection of viable sperm cells for clinical use.
Supplied as single-use kits, these media are intended for use in clinical settings such as fertility clinics and laboratories. The Puresperm 40 and Puresperm 80 are classified as Class II devices under FDA regulations (884.6180) and have received FDA 510K clearance and MDD compliance. Each kit includes sterile components for processing semen samples, adhering to aseptic handling protocols for reproductive medicine applications.
Frequently asked questions
What is the primary purpose of the Puresperm 40 and Puresperm 80 in clinical fertility treatments?
The Puresperm 40 and Puresperm 80 are designed to separate motile sperm from seminal plasma using density gradient centrifugation. This process isolates high-quality sperm cells, which are then used in assisted reproductive techniques to improve the chances of successful fertilization.
Are the Puresperm kits single-use or reusable, and why does this matter in a clinical setting?
The Puresperm 40 and Puresperm 80 are supplied as single-use kits, which ensures aseptic handling and reduces the risk of contamination. This is critical in fertility clinics and laboratories, where maintaining sterility is essential for patient safety and the integrity of reproductive procedures.
How do the Puresperm 40 and Puresperm 80 differ in their regulatory approval process?
Both devices received FDA 510(k) clearance and comply with the Medical Device Directive (MDD), confirming they meet regulatory standards for Class II devices under FDA classification 884.6180. The clearance was granted through a traditional review process by the Obstetrics/Gynecology advisory committee, ensuring their safety and effectiveness for semen processing.
What types of clinical settings are these devices intended for, and why?
The Puresperm 40 and Puresperm 80 are specifically intended for use in clinical settings like fertility clinics and laboratories. Their design supports assisted reproductive techniques, where precise sperm selection is required, and sterile processing is non-negotiable to ensure patient outcomes.
How are the Puresperm kits packaged, and what does this imply about their usability?
Each kit is packaged as a single-use unit containing sterile components, which implies minimal setup time and reduced risk of cross-contamination between patients. This streamlined packaging aligns with clinical workflows in fertility treatments, where efficiency and sterility are paramount.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K002623 | Class II | Active |
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Manufacturer
- Manufacturer
- Nidacon International Ab
Sources (2)
- FDA 510(k) K002623 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026