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510(k) DEN150010

Dignitana AB DigniCap System by Dignitana AB — Product Code PMC

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 8, 2015
Date Received
March 6, 2015
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scalp Cooling System
Device Class
Class II
Regulation Number
878.4360
Review Panel
SU
Submission Type

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.

Other clearances by Dignitana AB

  • K191166 — DigniCap Delta (June 26, 2019)
  • K170871 — DigniCap Scalp Cooling System (July 3, 2017)

Other clearances for product code PMC

  • K252289 — Eva Scalp Cooling System (November 25, 2025)
  • K211526 — Portable Scalp Cooling System (October 21, 2021)
  • K191166 — DigniCap Delta (June 26, 2019)
  • K173032 — Paxman Scalp Cooler (June 7, 2018)
  • K170871 — DigniCap Scalp Cooling System (July 3, 2017)
  • K163484 — Paxman Scalp Cooler (April 17, 2017)