510(k) Report

Devices descending from K991391

2 later devices reach PVP, Polyvinylpyrrolidone 10% (W/V) in Hepes-HTF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011607SpermcatchNidacon International AB20011—
+2K052457Picsi Sperm Selection DeviceBiocoat, Inc.20060—