HHI · System, Abortion, Vacuum
Obstetrics/Gynecology · 21 CFR 884.5070 · Class 2
Overview
| Product Code | HHI |
|---|---|
| Device Name | System, Abortion, Vacuum |
| Regulation | 21 CFR 884.5070 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K171440 | Berkeley VC-10 Vacuum Curettage System | Gyrus Acmi | Sep 29, 2017 | SESE |
| K030935 | BERKELEY V-10 VACUUM CURETTAGE SYSTEM | Acmi Corporation | Jun 23, 2003 | SESE |
| K983181 | CYTOPREP | Cytoprep Inc. Est. | Nov 16, 1998 | SESE |
| K931205 | MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER | Baxter Healthcare Corp | Mar 15, 1994 | SESE |
| K904160 | CYTOSMEAR BRUSH | Brooke Intl. | Nov 2, 1990 | SESE |
| K900641 | CANNULA, SUCTION UTERINE | Williams Specialty Products, Inc. | Mar 30, 1990 | SESE |
| K900642 | SWIVEL ADAPTER | Williams Specialty Products, Inc. | Mar 19, 1990 | SESE |
| K880734 | SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS | Personal Products Co. | Apr 25, 1988 | SESE |
| K873552 | CANNULA AND GENERAL PURPOSE ASPIRATOR | Cosmedtech, Inc. | Nov 25, 1987 | SESE |
| K870574 | COSMEDTECH GENERAL ASPIRATOR | Cosmedtech, Inc. | Mar 5, 1987 | SESE |
| K870560 | COSMEDTECH CANNULA | Cosmedtech, Inc. | Mar 4, 1987 | SESE |
| K862476 | LS3000 CANNULA UTERINE SUCTION | Engineering, Inc. | Jul 18, 1986 | SESE |
| K850312 | GYNASPYR VACUUM CURETTAGE UNIT | Roseburg SA | Feb 28, 1985 | SESE |
| K841631 | MODEL 3014 SUCTION UNIT | Forma Scientific, Inc. | Jul 3, 1984 | SESE |
| K840384 | DIAGNOSTIC DILATATION & MENSTRUAL KIT | Intl. Medical Technologies, Inc. | Apr 30, 1984 | SESE |
| K840383 | MENSTRUAL ASPIRATION KIT | Intl. Medical Technologies, Inc. | Apr 30, 1984 | SESE |
| K840382 | VACUUM ASPIRATION CATHETER | Intl. Medical Technologies, Inc. | Apr 30, 1984 | SESE |
| K840381 | TAPERED CERVICAL DILATOR | Intl. Medical Technologies, Inc. | Apr 30, 1984 | SESE |
| K840952 | MEDEVICE V-80 VACUUM PUMP | Berkeley Medevices | Mar 30, 1984 | SESE |
| K831112 | EPCOM VCU-1 VACUUM SYSTEM & CURETTE | Epcom Medical Systems, Inc. | Jun 30, 1983 | SESE |
Top Applicants
- Intl. Medical Technologies, Inc. — 4 clearances
- Cosmedtech, Inc. — 3 clearances
- Williams Specialty Products, Inc. — 2 clearances
- Acmi Corporation — 1 clearance
- American Hospital Supply Corp. — 1 clearance
