Search Results

The FALCON® IVF Four Well Plate is sterile, nonpyrogenic, embryotoxicity tested, singleuse plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.

The FALCON® IVF Four Well Plate is sterile (SAL of 10%), non-pyrogenic by Limulus Amebocyte Lysate (LAL of

The provided text describes a 510(k) summary for the FALCON® IVF Four Well Plate, a medical device used in assisted reproduction. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. The provided text focuses on the device description, intended use, and substantial equivalence to a predicate device, as required for a 510(k) submission.

Based on the available information, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document mentions several characteristics that serve as performance criteria for the device. These are inherent properties of the plate that ensure its suitability for IVF procedures.

Ask a specific question about this device