Berkeley VC-10 Vacuum Curettage System
FDA 510(k) K171440 · Gyrus Acmi
510(k) numberK171440
Submission
- Device name
- Berkeley VC-10 Vacuum Curettage System
- Applicant
- Gyrus Acmi
Southborough, MA, US - Received
- May 16, 2017
- Decision date
- September 29, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| K030935 | Berkeley V-10 Vacuum Curettage SystemHHI · Traditional | Acmi Corporation | 06/23/2003SE |
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| K873552 | Cannula and General Purpose AspiratorHHI · Traditional | Cosmedtech, Inc. | 11/25/1987SE |
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Questions and answers
When was Berkeley VC-10 Vacuum Curettage System cleared by the FDA?
Berkeley VC-10 Vacuum Curettage System (K171440) received a 510(k) decision of Substantially Equivalent on September 29, 2017, 136 days after the submission was received.
What is the product code of K171440?
The FDA product code is HHI – System, Abortion, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 884.5070.