Data / Medical devices / System, Abortion, Vacuum
System, Abortion, Vacuum (HHI): 9 FDA-registered makers in 6 countries
9 establishments in 6 countries are registered with the FDA to make System, Abortion, Vacuum (product code HHI, Class 2, 21 CFR 884.5070). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on September 29, 2017, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HHI
- Device class
- 2
- Regulation
- 884.5070
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| India | 1 |
| China | 1 |
| Taiwan | 1 |
| Germany | 1 |
| Mexico | 1 |
Makers of System, Abortion, Vacuum
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medgyn Products, Inc. | Westmont, IL, United States | Manufacturer, Repackager or relabeler | 4 | April 30, 1984 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 1 | September 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Manufacturer, Repackager or relabeler | 1 | April 30, 1984 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang, Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nissha Medical Technologies (Ohio), Inc. | Norwalk, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Hospital Supply Co., Ltd | Tongluo Township Miaoli, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Womancare Global | Salem, VA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 29, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.