510(k) Report

Devices descending from K102158

16 later devices reach Sigma Sterilization Pouch & Roll through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212338SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc.20215—
+1K180661SIGMA Sterilization Pouch and RollSigma Medical Supplies Corp.20182—
+1K162362PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical IndicatorPms Tibbi Cihazlar Teknolojisi San VE Tic AS20170—
+1K152669PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std20160—
+1K143637U&U Sterilization Pouch and RollU&U Medical Technology Co, Ltd.20154—
+2K243179Sterilization Pouch and RollYichang Xinxin Paper Products Co., Ltd.20250—
+2K241565Sterilization Package/ReelAnqing Clean Dental Instrument Technology Co., Ltd.20250—
+2K221875Sterilization Pouch and RollQianjiang Kingphar Medical Packaging & Printing Co., Ltd.20233—
+2K202462SIGMA Sterilization Pouch and RollSigma Medical Supplies Corporation20210—
+2K182184Paper Sterilization Pouch and Roll (Sterilization Pouch Flat, Sterilization Pouch…Mdk (Shanghai) Medical Packing Co., Ltd.20190—
+2K181957Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat…Tianchang Jiarui Packaging Material Co., Ltd.20190—
+2K162258Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd.20171—
+3K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.20260—
+3K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.20250—
+3K242898Sterilization Pouches and ReelsShanghai Jianzhong Medical Packaging Co., Ltd.20250—
+3K183356Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device…Weihai Xingtai Packaging Products Co., Ltd.20190—