Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5070](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5070) → HHI — System, Abortion, Vacuum # HHI · System, Abortion, Vacuum _Obstetrics/Gynecology · 21 CFR 884.5070 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI ## Overview - **Product Code:** HHI - **Device Name:** System, Abortion, Vacuum - **Regulation:** [21 CFR 884.5070](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5070) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K171440.md) | Berkeley VC-10 Vacuum Curettage System | Gyrus Acmi | Sep 29, 2017 | SESE | | [K030935](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K030935.md) | BERKELEY V-10 VACUUM CURETTAGE SYSTEM | Acmi Corporation | Jun 23, 2003 | SESE | | [K983181](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K983181.md) | CYTOPREP | Cytoprep Inc. Est. | Nov 16, 1998 | SESE | | [K931205](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K931205.md) | MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER | Baxter Healthcare Corp | Mar 15, 1994 | SESE | | [K904160](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K904160.md) | CYTOSMEAR BRUSH | Brooke Intl. | Nov 2, 1990 | SESE | | [K900641](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K900641.md) | CANNULA, SUCTION UTERINE | Williams Specialty Products, Inc. | Mar 30, 1990 | SESE | | [K900642](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K900642.md) | SWIVEL ADAPTER | Williams Specialty Products, Inc. | Mar 19, 1990 | SESE | | [K880734](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K880734.md) | SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS | Personal Products Co. | Apr 25, 1988 | SESE | | [K873552](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K873552.md) | CANNULA AND GENERAL PURPOSE ASPIRATOR | Cosmedtech, Inc. | Nov 25, 1987 | SESE | | [K870574](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K870574.md) | COSMEDTECH GENERAL ASPIRATOR | Cosmedtech, Inc. | Mar 5, 1987 | SESE | | [K870560](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K870560.md) | COSMEDTECH CANNULA | Cosmedtech, Inc. | Mar 4, 1987 | SESE | | [K862476](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K862476.md) | LS3000 CANNULA UTERINE SUCTION | Engineering, Inc. | Jul 18, 1986 | SESE | | [K850312](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K850312.md) | GYNASPYR VACUUM CURETTAGE UNIT | Roseburg SA | Feb 28, 1985 | SESE | | [K841631](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K841631.md) | MODEL 3014 SUCTION UNIT | Forma Scientific, Inc. | Jul 3, 1984 | SESE | | [K840384](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K840384.md) | DIAGNOSTIC DILATATION & MENSTRUAL KIT | Intl. Medical Technologies, Inc. | Apr 30, 1984 | SESE | | [K840383](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K840383.md) | MENSTRUAL ASPIRATION KIT | Intl. Medical Technologies, Inc. | Apr 30, 1984 | SESE | | [K840382](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K840382.md) | VACUUM ASPIRATION CATHETER | Intl. Medical Technologies, Inc. | Apr 30, 1984 | SESE | | [K840381](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K840381.md) | TAPERED CERVICAL DILATOR | Intl. Medical Technologies, Inc. | Apr 30, 1984 | SESE | | [K840952](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K840952.md) | MEDEVICE V-80 VACUUM PUMP | Berkeley Medevices | Mar 30, 1984 | SESE | | [K831112](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI/K831112.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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