Disposable Vacuum Curette
FDA 510(k) K790032 · British Marketing Ent., Ltd.
510(k) numberK790032
Submission
- Device name
- Disposable Vacuum Curette
- Applicant
- British Marketing Ent., Ltd.
Mchenry, IL, US - Received
- January 3, 1979
- Decision date
- February 1, 1979
- 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 |
| K890384 | Uterine CuretteHCY · Traditional | Kinetic Medical Products | 02/13/1989SE |
| 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 |
More from Gynemetrics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K782067 | Dilator, Mizutani Laminaria TentHDY · Traditional | 01/03/1979SE |
Questions and answers
When was Disposable Vacuum Curette cleared by the FDA?
Disposable Vacuum Curette (K790032) received a 510(k) decision of Substantially Equivalent on February 1, 1979, 29 days after the submission was received.
What is the product code of K790032?
The FDA product code is HCY – Curette, Uterine, a Class I (low risk) device regulated under 21 CFR 884.4530.