Synevac Vacuum Curettage Systems
FDA 510(k) K813282 · Synemed, Inc.
510(k) numberK813282
Submission
- Device name
- Synevac Vacuum Curettage Systems
- Applicant
- Synemed, Inc.
Walker, MI, US - Received
- November 17, 1981
- Decision date
- December 14, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHI – System, Abortion, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5070
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171440 | Berkeley VC-10 Vacuum Curettage SystemHHI · Special | Gyrus Acmi | 09/29/2017SE |
| K030935 | Berkeley V-10 Vacuum Curettage SystemHHI · Traditional | Acmi Corporation | 06/23/2003SE |
| K983181 | CytoprepHHI · Traditional | Cytoprep Inc. Est. | 11/16/1998SE |
| K931205 | Medi Vac Specimen Collector and TransporterHHI · Traditional | Baxter Healthcare Corp | 03/15/1994SE |
| K904160 | Cytosmear BrushHHI · Traditional | Brooke Intl. | 11/02/1990SE |
| K900641 | Cannula, Suction UterineHHI · Traditional | Williams Specialty Products, Inc. | 03/30/1990SE |
| K900642 | Swivel AdapterHHI · Traditional | Williams Specialty Products, Inc. | 03/19/1990SE |
| K880734 | Scented or Scented Deodorized Menstrual PadsHHI · Traditional | Personal Products Co. | 04/25/1988SE |
| K873552 | Cannula and General Purpose AspiratorHHI · Traditional | Cosmedtech, Inc. | 11/25/1987SE |
| K870574 | Cosmedtech General AspiratorHHI · Traditional | Cosmedtech, Inc. | 03/05/1987SE |
More from Cosmedtech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954037 | Field TrendHPT · Traditional | 11/17/1995SE |
| K852936 | The Fieldmaster Model 275HPT · Traditional | 10/15/1985SE |
| K833274 | Dermatology Handpiece-Ophth LaserHQF · Traditional | 12/03/1983SE |
| K831085 | Synevac Vacuum Source UnitBTA · Traditional | 06/08/1983SE |
| K828585 | Opthalas Photocoagulator · Traditional | 01/03/1983SE |
| K822853 | Model 200 SquidHPT · Traditional | 10/18/1982SE |
| K811270 | Scope MasterHIH · Traditional | 09/08/1981SE |
Questions and answers
When was Synevac Vacuum Curettage Systems cleared by the FDA?
Synevac Vacuum Curettage Systems (K813282) received a 510(k) decision of Substantially Equivalent on December 14, 1981, 27 days after the submission was received.
What is the product code of K813282?
The FDA product code is HHI – System, Abortion, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 884.5070.