Regulatory information

Regulatory information

Endo-SPONGE is a CE-marked class (class IIb) medical device

No manufacturer field safety notices or medical device alerts for this technology have been identified. One specialist commentator stated that they had reported an issue to the MHRA concerning a loose ring on the lubrication gel tube. The specialist stated that they had received confirmation from the company that the gel tube had been replaced and no longer has a loose ring.