Product Code: HHI FDA class 2 21 CFR 884.5070

System, Abortion, Vacuum

Obstetrics/Gynecology

The Vacuum Abortion System is an integrated assembly of components used to perform vacuum aspiration procedures for surgical termination of pregnancy or management of incomplete miscarriage, combining a suction source, controller, and cannula into a complete system. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HHI, regulated under 21 CFR 884.5070, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: HHI
Device Class: FDA class 2
Regulation Number: 884.5070
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K171440	Berkeley VC-10 Vacuum Curettage System	Sep 29, 2017	Substantially Equivalent	Gyrus Acmi
K030935	BERKELEY V-10 VACUUM CURETTAGE SYSTEM	Jun 23, 2003	Substantially Equivalent	Acmi Corporation
K983181	CYTOPREP	Nov 16, 1998	Substantially Equivalent	Cytoprep Inc. Est.
K931205	MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER	Mar 15, 1994	Substantially Equivalent	Baxter Healthcare Corp
K904160	CYTOSMEAR BRUSH	Nov 02, 1990	Substantially Equivalent	Brooke Intl.
K900641	CANNULA, SUCTION UTERINE	Mar 30, 1990	Substantially Equivalent	Williams Specialty Products, Inc.
K900642	SWIVEL ADAPTER	Mar 19, 1990	Substantially Equivalent	Williams Specialty Products, Inc.
K880734	SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS	Apr 25, 1988	Substantially Equivalent	Personal Products Co.
K873552	CANNULA AND GENERAL PURPOSE ASPIRATOR	Nov 25, 1987	Substantially Equivalent	Cosmedtech, Inc.
K870574	COSMEDTECH GENERAL ASPIRATOR	Mar 05, 1987	Substantially Equivalent	Cosmedtech, Inc.
K870560	COSMEDTECH CANNULA	Mar 04, 1987	Substantially Equivalent	Cosmedtech, Inc.
K862476	LS3000 CANNULA UTERINE SUCTION	Jul 18, 1986	Substantially Equivalent	Engineering, Inc.
K850312	GYNASPYR VACUUM CURETTAGE UNIT	Feb 28, 1985	Substantially Equivalent	Roseburg SA
K841631	MODEL 3014 SUCTION UNIT	Jul 03, 1984	Substantially Equivalent	Forma Scientific, Inc.
K840384	DIAGNOSTIC DILATATION & MENSTRUAL KIT	Apr 30, 1984	Substantially Equivalent	Intl. Medical Technologies, Inc.
K840383	MENSTRUAL ASPIRATION KIT	Apr 30, 1984	Substantially Equivalent	Intl. Medical Technologies, Inc.
K840382	VACUUM ASPIRATION CATHETER	Apr 30, 1984	Substantially Equivalent	Intl. Medical Technologies, Inc.
K840381	TAPERED CERVICAL DILATOR	Apr 30, 1984	Substantially Equivalent	Intl. Medical Technologies, Inc.
K840952	MEDEVICE V-80 VACUUM PUMP	Mar 30, 1984	Substantially Equivalent	Berkeley Medevices
K831112	EPCOM VCU-1 VACUUM SYSTEM & CURETTE	Jun 30, 1983	Substantially Equivalent	Epcom Medical Systems, Inc.
K813282	SYNEVAC VACUUM CURETTAGE SYSTEMS	Dec 14, 1981	Substantially Equivalent	Synemed, Inc.
K802360	UTERINE VACUM ASPIRATING CURRETTE	Oct 31, 1980	Substantially Equivalent	American Hospital Supply Corp.
K800833	VABRA ASPIRATOR	May 14, 1980	Substantially Equivalent	Cooper Medical Devices Corp.
K780387	VABRA ABORTION UNIT	Apr 12, 1978	Substantially Equivalent	Cooper Laboratories