DigniCap Delta
FDA 510(k) clearance K191166 · decided 2019-06-26
Clearance details
- K-number
- K191166
- Device name
- DigniCap Delta
- Applicant
- Dignitana, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-01
- Decision date
- 2019-06-26
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- PMC
- Device class
- 2
- Regulation number
- 878.4360
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Eva Scalp Cooling System (K252289) | Stemtech Medical Devices Private Limited | 2025-11-25 |
| Portable Scalp Cooling System (K211526) | Cooler Heads Care, Inc. | 2021-10-21 |
| Paxman Scalp Cooler (K173032) | Paxman Coolers Limited | 2018-06-07 |
| DigniCap Scalp Cooling System (K170871) | Dignitana AB | 2017-07-03 |
| Paxman Scalp Cooler (K163484) | Paxman Coolers Limited | 2017-04-17 |
| Dignitana AB DigniCap System (DEN150010) | Dignitana AB | 2015-12-08 |
Recalls involving this device
No recalls on record reference this clearance.