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510(k) K191166

DigniCap Delta by Dignitana, Inc. — Product Code PMC

K191166 is an FDA 510(k) premarket notification submitted by Dignitana, Inc. for the device "DigniCap Delta". The FDA issued a decision of Substantially Equivalent on June 26, 2019. The device falls under product code PMC (Scalp Cooling System), a Class II device regulated under 21 CFR 878.4360. Dignitana, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2019
Date Received
May 1, 2019
Clearance Type
Traditional
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, Inc.

  • K170871 — DigniCap Scalp Cooling System (July 3, 2017)
  • DEN150010 — Dignitana AB DigniCap System (December 8, 2015)

Other clearances for product code PMC

  • K252289 — Eva Scalp Cooling System (November 25, 2025)
  • K211526 — Portable Scalp Cooling System (October 21, 2021)
  • K173032 — Paxman Scalp Cooler (June 7, 2018)
  • K170871 — DigniCap Scalp Cooling System (July 3, 2017)
  • K163484 — Paxman Scalp Cooler (April 17, 2017)
  • DEN150010 — Dignitana AB DigniCap System (December 8, 2015)

FDA data resources