Cannula and General Purpose Aspirator
FDA 510(k) K873552 · Cosmedtech, Inc.
510(k) numberK873552
Submission
- Device name
- Cannula and General Purpose Aspirator
- Applicant
- Cosmedtech, Inc.
Mission Viejo, CA, US - Received
- August 10, 1987
- Decision date
- November 25, 1987
- 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
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| 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 |
| K870574 | Cosmedtech General AspiratorHHI · Traditional | Cosmedtech, Inc. | 03/05/1987SE |
| K870560 | Cosmedtech CannulaHHI · Traditional | Cosmedtech, Inc. | 03/04/1987SE |
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Questions and answers
When was Cannula and General Purpose Aspirator cleared by the FDA?
Cannula and General Purpose Aspirator (K873552) received a 510(k) decision of Substantially Equivalent on November 25, 1987, 107 days after the submission was received.
What is the product code of K873552?
The FDA product code is HHI – System, Abortion, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 884.5070.