Dignitana AB

Lund Skane, SE

DIGNITANA AB appears in FDA device records in Lund Skane, SE. FDA records list 3 510(k) clearances between 2015-12-08 and 2019-06-26, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 1
Registered establishments: 2

510(k) clearance history

FDA records hold 3 510(k) clearances for Dignitana AB between 2015 and 2019. The busiest year on record is 2015, with 1. The most recent is 2019, with 1.

Clearances by year, as a table

510(k) clearance decisions for Dignitana AB, by decision year
Year	Clearances
2015	1
2017	1
2019	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K191166	DigniCap Delta	PMC	Substantially Equivalent	2019-06-26
K170871	DigniCap Scalp Cooling System	PMC	Substantially Equivalent	2017-07-03
DEN150010	Dignitana AB DigniCap System	PMC	Unknown	2015-12-08

Registered establishments

FDA registered establishments for Dignitana AB, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3008888703	3008888703	DIGNITANA AB	Traktorgranden 3, Lund Skane 22660 SE	2026	PMC
3012146457	3012146457	Dignitana, Inc.	10925 Estate Lane, Dallas, TX 75238 US	2026	PMC

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

PMCScalp Cooling System

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0825-2022	DigniCap Delta Scalp Cooling System, Product Number: 900-1001, 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 Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US,	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.	Class II	2021-11-05	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain