Sound, Uterine

FDA product code HHM · Class I (low risk) · 21 CFR 884.4530 · Obstetrics/Gynecology

10510(k) clearances
0PMA approvals
4recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K011840Cervilenz Uterine Measuring SoundHHM · Traditional Cervilenz, Inc.08/10/2001SE
K935665Intrauterine SoundHHM · Traditional Rocket of London, Ltd.02/24/1994SE
K884684Rocket Intrauterine Depth SoundHHM · Traditional A & A Medical, Inc.12/20/1988SE
K883806Rocket Intrauterine SoundHHM · Traditional A & A Medical, Inc.10/31/1988SE
K870550Teflon Uterine SoundHHM · Traditional Cook Ob/Gyn03/04/1987SE
K840380Uterine SoundHHM · Traditional Intl. Medical Technologies, Inc.04/30/1984SE
K831224Augros HysterometerHHM · Traditional Axcan Scientific Corp.10/28/1983SE
K802315Uterine SoundHHM · Traditional Gynemetrics, Inc.01/12/1981SE
K781766Uterine Sound, Burnett DisposableHHM · Traditional C.R. Bard, Inc.12/07/1978SE
K760170Intrauterine Sound, Plastic DisposableHHM · Traditional G.D. Searle and Co.07/19/1976SE

Recalls

RecallProductFirmInitiated
Z-3189-2024 Class IIStainless Steel Sims Uterine Sound, Part Number 64-601During the manufacturing process the devices were laser-marked with the incorrect part number. CooperSurgical, Inc.07/31/2024Open, Classified
Z-3188-2024 Class IISilver-Plated Copper Sims Uterine Sound, Part Number 64-600During the manufacturing process the devices were laser-marked with the incorrect part number. CooperSurgical, Inc.07/31/2024Open, Classified
Z-1068-2020 Class IICenturion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790Incomplete seals on the sterile package may compromise the sterility Centurion Medical Products Corporation12/11/2019Terminated
Z-0655-2017 Class IISURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22…Breach in sterile barrier compromising product sterility Hologic, Inc10/28/2016Terminated