Uterine Sound

FDA 510(k) K802315 · Gynemetrics, Inc.

Substantially Equivalent

510(k) numberK802315

Submission

Device name
Uterine Sound
Applicant
Gynemetrics, Inc.
Mchenry, IL, US
Received
September 23, 1980
Decision date
January 12, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HHM – Sound, Uterine
Device class
Class I (low risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HHM

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
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

More from G.D. Searle and Co.

510(k)DeviceDecision
K811568Cervical DilatorHDQ · Traditional 07/16/1981SE
K803210Menstrual Aspiration KitsHHK · Traditional 01/28/1981SE
K802313Uterine CuretteHCY · Traditional 01/12/1981SE

Questions and answers

When was Uterine Sound cleared by the FDA?

Uterine Sound (K802315) received a 510(k) decision of Substantially Equivalent on January 12, 1981, 111 days after the submission was received.

What is the product code of K802315?

The FDA product code is HHM – Sound, Uterine, a Class I (low risk) device regulated under 21 CFR 884.4530.