Data / Medical devices / United States / Pixie, Inc.
Pixie, Inc.: FDA-registered device maker in New York, NY, United States, 3 510(k) clearances
Pixie, Inc. is registered with the FDA (registration 3019735068) in New York, NY, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 23, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019735068
- Address
- 114 East 90th Street Apt 7B, New York, NY, United States, 10128
- Owner or operator
- Pixie, Inc. (10082312)
- Roles
- Specification developer
- First device listed
- August 7, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tampon, Menstrual, Scented, Scented-Deodorized | HIL | 2 | Specification developer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Specification developer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Specification developer | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 23, 2020 | K203257 | LUBi Water Based Personal Lubricant | NUC | Substantially Equivalent | Boya Biotechnology Co., Ltd. | accessdata.fda.gov |
| December 7, 2006 | K062001 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | HEB | Substantially Equivalent | Rostam , Ltd. | accessdata.fda.gov |
| November 23, 2004 | K042773 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | HIL | Substantially Equivalent | Rostam , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tampon, Menstrual, Unscented
- All makers of Pad, Menstrual, Unscented
- All makers of Lubricant, Personal
- All makers of Tampon, Menstrual, Scented, Scented-Deodorized
Updated December 23, 2020. 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.