510(k) Report

Devices descending from K041395

4 later devices reach EG-3630UR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061068EG-3670URKPentax Medical Company200631
+2K090196EG-3670URKPentax Medical Company200921
+3K130206Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc.20131—
+4K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.20240—