Submission Details
| 510(k) Number | K171440 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 16, 2017 |
| Decision Date | September 29, 2017 |
| Days to Decision | 136 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Special
Berkeley VC-10 Vacuum Curettage System
Sep 2017
Decision
136d
Days
Class 2
Risk
About This 510(k) Submission
K171440 is an FDA 510(k) clearance for the Berkeley VC-10 Vacuum Curettage System, a System, Abortion, Vacuum (Class II — Special Controls, product code HHI), submitted by Gyrus Acmi (Southborough, US). The FDA issued a Cleared decision on September 29, 2017, 136 days after receiving the submission on May 16, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.
Device Classification
| Product Code | HHI — System, Abortion, Vacuum |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5070 |
Manufacturer
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