Data / Medical devices / United States / Necessaire, Inc
Necessaire, Inc: FDA-registered device maker in Manhattan Beach, CA, United States, 1 510(k) clearance
Necessaire, Inc is registered with the FDA (registration 3015272252) in Manhattan Beach, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 10, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015272252
- Address
- 1601 N Sepulveda Blvd. #781, Manhattan Beach, CA, United States, 90266
- Owner or operator
- Necessaire, Inc (10059667)
- Roles
- Specification developer
- First device listed
- February 8, 2019
- Registered through
- 2026
- Brand names listed
- The Sex Gel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 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 |
|---|---|---|---|---|---|---|
| September 10, 2018 | K181078 | The Sex Gel | NUC | Substantially Equivalent | Necessaire, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 10, 2018. 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.