510(k) Report

Devices descending from K961048

5 later devices reach Olympus MH-246R Balloon Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982733Olympus MH-246R Balloon Sheath, for Bronchial UseThe Olympus Optical Co.19981—
+1K982725Olympus MH-246R Balloon Sheath, for Female Reproductive Tract UseOlympus America, Inc.19980—
+1K982734Olympus MH-246R Balloon Sheath, for Urinary Tract UseThe Olympus Optical Co.19981—
+2K994106Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial UseOlympus America, Inc.20000—
+2K994069Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary UseOlympus America, Inc.20000—