Data / Medical devices / United States / Nexgel, Inc.
Nexgel, Inc.: FDA-registered device maker in Langhorne, PA, United States, 2 510(k) clearances
Nexgel, Inc. is registered with the FDA (registration 3016807311) in Langhorne, PA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 22, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3016807311
- Address
- 2150 Cabot Blvd W Suite B, Langhorne, PA, United States, 19047
- Owner or operator
- NEXGEL, Inc. (10072529)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- April 29, 2020
- Registered through
- 2026
- Brand names listed
- NEXGEL, SILVERSEAL, SilverSeal
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 22, 2017 | K171041 | SilverSeal | FRO | Substantially Equivalent | Alliqua Biomedical, Inc. | accessdata.fda.gov |
| July 23, 2004 | K040019 | SILVERSEAL | MGQ | Substantially Equivalent | Noble Fiber Technologies | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Updated August 22, 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.