510(k) Report

Devices descending from K180661

2 later devices reach SIGMA Sterilization Pouch and Roll through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243179Sterilization Pouch and RollYichang Xinxin Paper Products Co., Ltd.20250—
+1K202462SIGMA Sterilization Pouch and RollSigma Medical Supplies Corporation20210—