Identifiers
- 510(k) Number
- K113786 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 SpermFreeze Solution is a reproductive media designed for the cryopreservation of human sperm. Classified as a media device under FDA classification II, it is intended to preserve sperm viability, genetic integrity, and functional capacity during freezing and thawing processes. This egg-yolk-free formulation supports optimal sperm survival and maintains DNA stability, which are critical for assisted reproductive technologies.
This solution is supplied as a sterile, single-use product and is regulated under FDA 510(k) clearance (K113786) with a decision date of October 26, 2012. It is intended for use in clinical settings, such as fertility clinics, where assisted reproduction procedures are performed. Storage and handling must comply with standard cryopreservation protocols to ensure sterility and efficacy. The device is categorized under the medical specialty of Obstetrics/Gynecology and adheres to FDA regulation 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: SpermFreeze Solution™ - Vitrolife, PDF Summary of safety and clinical performance: Doc. ID: SpermFreeze Solution, SpermFreeze Solution — Vitrolife Sweden AB SDS & Risk Assessment | ISDSS, SPERMFREEZE SOLUTION (K113786) — FDA 510(k) | Innolitics, SpermFreeze Solution™ - Vitrolife
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113786 | Class II | Active |
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Manufacturer
- Manufacturer
- Vitrolife Sweden AB
Sources (1)
- FDA 510(k) K113786 24 fields · synced Oct 6, 2026