510(k) Report

Devices descending from K090371

9 later devices reach Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140487Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20148—
+2K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti20160—
+2K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20166—
+3K172749Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20185—
+4K183401Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20193—
+4K183297Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20190—
+5K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris20222—
+6K231501PRO-LITE Sterilization TraySTERIS Corporation20230—
+6K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation20230—