The following data is part of a premarket notification filed by Gyrus Acmi with the FDA for Berkeley Vc-10 Vacuum Curettage System.
| Device ID | K171440 |
| 510k Number | K171440 |
| Device Name: | Berkeley VC-10 Vacuum Curettage System |
| Classification | System, Abortion, Vacuum |
| Applicant | Gyrus ACMI 136 Turnpike Rd Southborough, MA 01772 |
| Contact | Christina Flores |
| Correspondent | Christina Flores Gyrus ACMI 136 Turnpike Rd Southborough, MA 01772 |
| Product Code | HHI |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-16 |
| Decision Date | 2017-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925037908 | K171440 | 000 |
| 00821925004719 | K171440 | 000 |
| 00821925004689 | K171440 | 000 |
| 00821925001046 | K171440 | 000 |
| 00821925001022 | K171440 | 000 |
| 00821925001015 | K171440 | 000 |
| 00821925000995 | K171440 | 000 |
| 00821925000964 | K171440 | 000 |
| 00821925000940 | K171440 | 000 |
| 00821925008632 | K171440 | 000 |
| 00821925004184 | K171440 | 000 |
| 00821925030862 | K171440 | 000 |
| 00821925004726 | K171440 | 000 |
| 00821925004610 | K171440 | 000 |
| 00821925037892 | K171440 | 000 |
| 00821925037861 | K171440 | 000 |
| 00821925000223 | K171440 | 000 |
| 00821925000179 | K171440 | 000 |
| 00821925004481 | K171440 | 000 |
| 00821925004207 | K171440 | 000 |
| 00821925038196 | K171440 | 000 |
| 00821925004696 | K171440 | 000 |
| 00821925001008 | K171440 | 000 |
| 00821925005341 | K171440 | 000 |
| 00821925004627 | K171440 | 000 |
| 00821925009561 | K171440 | 000 |