Data / Medical devices / United States / Medcura, Inc. (fka Gel-E, Inc.)
Medcura, Inc. (fka Gel-E, Inc.): FDA-registered device maker in Riverdale, MD, United States, 1 510(k) clearance
Medcura, Inc. (fka Gel-E, Inc.) is registered with the FDA (registration 3016844359) in Riverdale, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 25, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016844359
- Address
- 5650 Rivertech Ct. Ste S, Riverdale, MD, United States, 20737
- Owner or operator
- Savannah Therapeutics, Inc. (10096321)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 3, 2026
- Registered through
- 2026
- Brand names listed
- CutCure Wound Gel, Rapid Seal Wound Gel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 25, 2019 | K192667 | gel-e Flex+ gel OTC | QSY | Substantially Equivalent | Gel-E, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 25, 2019. 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.