510(k) Report

Devices descending from K974768

3 later devices reach Pdi Sterile Lubricating Jelly through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131617Colonglide (R) LubricantPediatric Pharmaceuticals, Inc.20130—
+1K073684Sheffield Pharmaceuticals (Sterile) LubrigelSheffield Industries, Div. of Faria, Ltd.200811
+2K101522Ultra Seal Sterile Lubricating JellyUltra Seal Corporation20100—