Uterine Curette
FDA 510(k) K890384 · Kinetic Medical Products
510(k) numberK890384
Submission
- Device name
- Uterine Curette
- Applicant
- Kinetic Medical Products
Erie, PA, US - Received
- January 23, 1989
- Decision date
- February 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K980096 | Oac (Optical Aspirating Curette)HCY · Traditional | Imagyn Medical Technologies, Inc. | 05/01/1998SE |
| K944238 | Endocyte TMHCY · Traditional | D.L. Nelson and Assoc., Inc. | 09/15/1995SE |
| K935822 | Phase I CuretteHCY · Traditional | Phase I Corp. | 04/28/1994SE |
| K901442 | Baxter D & C TrayHCY · Traditional | Baxter Healthcare Corp | 07/26/1990SE |
| K881794 | Ivory Finder SetHCY · Traditional | Ivory Instruments Co. | 07/08/1988SE |
| K862297 | The D & C Pad-SacHCY · Traditional | Nu-Gyn-Tek, Inc. | 07/07/1986SE |
| K850068 | Lune Au CurettesHCY · Traditional | Luneau Laboratories | 04/08/1985SE |
| K841004 | Surgical Curette, VariousHCY · Traditional | Premier Dental Products Co. | 05/11/1984SE |
| K802313 | Uterine CuretteHCY · Traditional | Gynemetrics, Inc. | 01/12/1981SE |
| K790032 | Disposable Vacuum CuretteHCY · Traditional | British Marketing Ent., Ltd. | 02/01/1979SE |
More from British Marketing Ent., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K890385 | Midwifery/Obstetrical ForcepsHDA · Traditional | 03/01/1989SE |
| K890387 | Malleable Placenta CuretteHEX · Traditional | 02/27/1989SE |
| K890382 | Compression ForcepsHFW · Traditional | 02/27/1989SE |
| K890380 | Cervical Biopsy ForcepsHFB · Traditional | 02/27/1989SE |
| K890376 | Vaginal SpeculumHFD · Traditional | 02/27/1989SE |
| K890383 | Hysterectomy ForcepsHCZ · Traditional | 02/16/1989SE |
| K890216 | Microsurgical KeratomeGZX · Traditional | 02/16/1989SE |
| K890389 | Umbilical ScissorsHDJ · Traditional | 02/13/1989SE |
| K890388 | Cephalotomy ScissorsKNB · Traditional | 02/13/1989SE |
| K890386 | Placenta and Ovum ForcepsHCZ · Traditional | 02/13/1989SE |
Questions and answers
When was Uterine Curette cleared by the FDA?
Uterine Curette (K890384) received a 510(k) decision of Substantially Equivalent on February 13, 1989, 21 days after the submission was received.
What is the product code of K890384?
The FDA product code is HCY – Curette, Uterine, a Class I (low risk) device regulated under 21 CFR 884.4530.