510(k) Report

Devices descending from K183398

3 later devices reach Endoform Restella through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241126OviTex PRSTELA Bio, Inc.20240—
+1K214070OviTex PRS (Long Term Resorbable)Tela Bio20231—
+2K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.20240—