510(k) Report

Devices descending from K820302

13 later devices reach Surgipeel Self-Seal Packaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070765Vis-U-All II Self Seal PouchSTERIS Corporation200712—
+2K141412Sterilucent Self-Seal Sterilization PouchGs Medical Packaging, Inc.20140—
+2K092745Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide, Models: Self and…STERIS Corporation201011
+2K090371Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization SystemSTERIS Corporation20099—
+3K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation20230—
+3K140487Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20148—
+4K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti20160—
+4K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20166—
+5K172749Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20185—
+6K183401Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20193—
+6K183297Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20190—
+7K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris20222—
+8K231501PRO-LITE Sterilization TraySTERIS Corporation20230—