Berkeley VC-10 Vacuum Curettage System
FDA 510(k) clearance K171440 · decided 2017-09-29
Clearance details
- K-number
- K171440
- Device name
- Berkeley VC-10 Vacuum Curettage System
- Applicant
- Gyrus Acmi
- Decision
- Substantially Equivalent
- Date received
- 2017-05-16
- Decision date
- 2017-09-29
- Days to decision
- 136 days
- Clearance type
- Special
- Product code
- HHI
- Device class
- 2
- Regulation number
- 884.5070
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Southborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BERKELEY V-10 VACUUM CURETTAGE SYSTEM (K030935) | Acmi Corporation | 2003-06-23 |
| CYTOPREP (K983181) | Cytoprep Inc. Est. | 1998-11-16 |
| MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER (K931205) | Baxter Healthcare Corp | 1994-03-15 |
| CYTOSMEAR BRUSH (K904160) | Brooke Intl. | 1990-11-02 |
| CANNULA, SUCTION UTERINE (K900641) | Williams Specialty Products, Inc. | 1990-03-30 |
| SWIVEL ADAPTER (K900642) | Williams Specialty Products, Inc. | 1990-03-19 |
| SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (K880734) | Personal Products Co. | 1988-04-25 |
| CANNULA AND GENERAL PURPOSE ASPIRATOR (K873552) | Cosmedtech, Inc. | 1987-11-25 |
| COSMEDTECH GENERAL ASPIRATOR (K870574) | Cosmedtech, Inc. | 1987-03-05 |
| COSMEDTECH CANNULA (K870560) | Cosmedtech, Inc. | 1987-03-04 |
| LS3000 CANNULA UTERINE SUCTION (K862476) | Engineering, Inc. | 1986-07-18 |
| GYNASPYR VACUUM CURETTAGE UNIT (K850312) | Roseburg SA | 1985-02-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of t recall (Z-0078-2023) | Olympus Corporation of the Americas | 2022-10-12 |