TSO3 Files for an Extended Claim for Duodenoscopes
TSO3 filed a 510(k) submission with US regulators for its STERIZONE VP4 Sterilizer.
TSO3 (TSX:TOS) filed a 510(k) submission with US regulators for its STERIZONE VP4 Sterilizer.
As quoted in the press release:
If awarded such claim, TSO3‘s STERIZONE® VP4 Sterilizer would become the first and only validated sterilizer technology in the US with a cleared label claim for the terminal sterilization of duodenoscopes.
TSO3‘s filing is supported by laboratory data that validates that the STERIZONE® VP4 Sterilizer, with its dual sterilants of hydrogen peroxide and ozone, can terminally sterilize multi-channel flexible endoscopes with a distal end elevator mechanism (duodenovideoscopes). If achieved, the claim will match existing claims already made by the Company in Canada and Europe.
Click here to read the full press release.
Source: www.newswire.ca
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