Clearance and Assessment Documents

Who Cleared What, and When

The 14 FDA 510(k) documents in the archive belong to 6 manufacturers. The 510(k) route shows that a device is substantially equivalent to one already on the market; it does not show that its efficacy was demonstrated.

How many assessments each body published

The 25 health technology assessments come from 7 bodies. The existence of a report does not mean a favourable decision: some of the documents here are suspension and consultation decisions.

The records on this page are not included in the portal's publication counts. The oncology corpus and the extended electroporation corpus count electroporation publications only; the documents here are kept in the source archive as context and are reported with their own figures.

The Full Set of Documents

That a device is cleared does not mean its efficacy has been demonstrated; the 510(k) route shows substantial equivalence to a device already on the market. Likewise the existence of an HTA report does not mean a favourable decision: some of the documents here are suspension and consultation decisions.

FDA 510(k) Clearances

Premarket notifications issued by the US Food and Drug Administration for electroporation devices. A clearance is not a publication; it records when, for which manufacturer and under which description a device was cleared.

Health Technology Assessments

Assessment reports published by bodies such as NICE, G-BA, IQWiG, AIHTA and LBI-HTA. They show how an indication is assessed at country level; they interpret evidence rather than produce it.

Trial Registration Records

Trial registration records taken from the ISRCTN registry. The machine-readable export of the registry is processed separately on the Clinical Trials page; the documents here are the registry's own PDF.

Manufacturer Instructions for Use

Instructions for use, technical sheets and brochures published by device manufacturers. These are the manufacturer's own statements, not independent assessments.