Uterine Curette

FDA 510(k) K802313 · Gynemetrics, Inc.

Substantially Equivalent

510(k) numberK802313

Submission

Device name
Uterine Curette
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
HCY – Curette, Uterine
Device class
Class I (low risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HCY

510(k)DeviceApplicantDecision
K980096Oac (Optical Aspirating Curette)HCY · Traditional Imagyn Medical Technologies, Inc.05/01/1998SE
K944238Endocyte TMHCY · Traditional D.L. Nelson and Assoc., Inc.09/15/1995SE
K935822Phase I CuretteHCY · Traditional Phase I Corp.04/28/1994SE
K901442Baxter D & C TrayHCY · Traditional Baxter Healthcare Corp07/26/1990SE
K890384Uterine CuretteHCY · Traditional Kinetic Medical Products02/13/1989SE
K881794Ivory Finder SetHCY · Traditional Ivory Instruments Co.07/08/1988SE
K862297The D & C Pad-SacHCY · Traditional Nu-Gyn-Tek, Inc.07/07/1986SE
K850068Lune Au CurettesHCY · Traditional Luneau Laboratories04/08/1985SE
K841004Surgical Curette, VariousHCY · Traditional Premier Dental Products Co.05/11/1984SE
K790032Disposable Vacuum CuretteHCY · Traditional British Marketing Ent., Ltd.02/01/1979SE

More from British Marketing Ent., Ltd.

510(k)DeviceDecision
K811568Cervical DilatorHDQ · Traditional 07/16/1981SE
K803210Menstrual Aspiration KitsHHK · Traditional 01/28/1981SE
K802315Uterine SoundHHM · Traditional 01/12/1981SE

Questions and answers

When was Uterine Curette cleared by the FDA?

Uterine Curette (K802313) 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 K802313?

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