K191166 is an FDA 510(k) clearance for the DigniCap Delta. This device is classified as a Scalp Cooling System (Class II - Special Controls, product code PMC).
Submitted by Dignitana, Inc. (Dallas, US). The FDA issued a Cleared decision on June 26, 2019, 56 days after receiving the submission on May 1, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4360. A Scalp Cooling System Is Intended To Reduce Or Prevent The Frequency And Severity Of Alopecia During Chemotherapy In Which Alopecia-inducing Chemotherapeutic Agents Are Used..
| 510(k) Number | K191166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2019 |
| Decision Date | June 26, 2019 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PMC - Scalp Cooling System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4360 |
| Definition | A Scalp Cooling System Is Intended To Reduce Or Prevent The Frequency And Severity Of Alopecia During Chemotherapy In Which Alopecia-inducing Chemotherapeutic Agents Are Used. |