Data / Medical devices / United States / Dignitana, Inc.
Dignitana, Inc.: FDA-registered device maker in Dallas, TX, United States, 1 510(k) clearance
Dignitana, Inc. is registered with the FDA (registration 3012146457) in Dallas, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 26, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012146457
- Address
- 10925 Estate Lane Suite W-185, Dallas, TX, United States, 75238
- Owner or operator
- Dignitana Inc (10050834)
- Roles
- Specification developer
- First device listed
- August 16, 2019
- Registered through
- 2026
- Brand names listed
- DigniCap Delta
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Scalp Cooling System | PMC | 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 |
|---|---|---|---|---|---|---|
| June 26, 2019 | K191166 | DigniCap Delta | PMC | Substantially Equivalent | Dignitana, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 5, 2021 | 89056 | Class II | Terminated | DigniCap Delta Scalp Cooling System, Product Number:, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap D | Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up depending on environmental conditions with instructions. | accessdata.fda.gov |
Compare with other makers
Updated June 26, 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.