FDA Product Code
FDA Product Code PMC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4360
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252289 | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited | 2025-11-25 | Traditional | PDF ↗ |
| K211526 | Portable Scalp Cooling System | Cooler Heads Care, Inc. | 2021-10-21 | Traditional | PDF ↗ |
| K191166 | DigniCap Delta | Dignitana, Inc. | 2019-06-26 | Traditional | PDF ↗ |
| K173032 | Paxman Scalp Cooler | Paxman Coolers Limited | 2018-06-07 | Traditional | PDF ↗ |
| K170871 | DigniCap Scalp Cooling System | Dignitana AB | 2017-07-03 | Traditional | PDF ↗ |
| K163484 | Paxman Scalp Cooler | Paxman Coolers Limited | 2017-04-17 | Traditional | PDF ↗ |
| DEN150010 | Dignitana AB DigniCap System | Dignitana AB | 2015-12-08 | Direct | — |
Product code PMC · Class II · General, Plastic Surgery. Data: openFDA.