Source, Abortion Unit, Vacuum
The Vacuum Abortion Unit Source is a component of a vacuum-based uterine aspiration system that provides the suction source used to evacuate uterine contents during surgical termination of pregnancy or management of miscarriage. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGF, regulated under 21 CFR 884.5070, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HGF
- Device Class
- FDA class 2
- Regulation Number
- 884.5070
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K945179 | BOTTLE COLLECTION SET | Jan 26, 1995 | Substantially Equivalent | Medgyn Products, Inc. |
| K905115 | BIOVISION ENDOCULAR PROBE | Feb 11, 1991 | Substantially Equivalent | Douglas James Donaldson Compliance Services |
| K904248 | MODEL GLASE 210 HOLMIUM LASER SYSTEM | Dec 14, 1990 | Substantially Equivalent | Charles L. Rose and Co., Inc. |
| K890787 | O-020 LASER INDIRECT OPHTHALMOSCOPE | Mar 24, 1989 | Substantially Equivalent | Hgm Medical Laser Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.