title: Medical devices; general and plastic surgery devices; classification of the nonabsorbable expandable hemostatic sponge for temporary internal use. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the nonabsorbable expandable hemostatic sponge for temporary internal use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the nonabsorbable expandable hemostatic sponge for temporary internal use classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D006489:Hemostatic Techniques / Q000145:classification* / Q000295:instrumentation; D006801:Humans; D062307:Medical Device Legislation; D015503:Surgical Sponges / Q000145:classification*; D014481:United States