510(k) Report

Devices descending from K133420

6 later devices reach Tranquill Barbed Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190264ViolaMeditime Co., Ltd.20190—
+1K172602MiracuFeeltech Co., Ltd.20184—
+2K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.20250—
+2K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…Hyundae Meditech Co., Ltd.20241—
+2K190245PDS Barbed Suture, PDO MAXX ThreadsPdo Max, Inc.20190—
+3K242571Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150…Hyundae Meditech Co., Ltd.20240—