510(k) Report

Devices descending from K851895

2 later devices reach Polygel Ultrasound Gel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992152General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity…CIVCO Medical Instruments Co., Inc.19991—
+2K080119ClearscanEsi, Inc.20080—