Data / Medical devices / United States / Seventh Generation
Seventh Generation: FDA-registered device maker in South Burlington, VT, United States, 3 510(k) clearances
Seventh Generation is registered with the FDA (registration 1648563) in South Burlington, VT, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 3, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1648563
- FEI number
- 3000205942
- Address
- 530 Community Dr, South Burlington, VT, United States, 05403
- Owner or operator
- SEVENTH GENERATION Inc. (9024698)
- Roles
- Complaint file establishment
- First device listed
- August 2, 2000
- Registered through
- 2027
- Brand names listed
- ORGANIC ESSENTIALS, Pad Maxi Overnight with Wings, Pad Maxi Regular (no wings), Pad Ultrathin Overnight with Wings, Pad Ultrathin Regular with Wings, Pad Ultrathin Super Long with Wings, Pantiliner, SEVENTH GENERATION and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pad, Menstrual, Unscented | HHD | 1 | Complaint file establishment | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 3, 2017 | K162746 | Ontex and other proprietary names | HEB | Substantially Equivalent | Ontex Bvba | accessdata.fda.gov |
| December 23, 2009 | K090819 | ONTEX TAMPON (UNSCENTED) | HEB | Substantially Equivalent | Ontex International NV | accessdata.fda.gov |
| November 9, 1998 | K983478 | ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON | HEB | Substantially Equivalent | Organic Essentials | accessdata.fda.gov |
Compare with other makers
Updated March 3, 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.