DigniCap Scalp Cooling System— 510(k) K170871

Substantially Equivalent

Dignitana AB

FDA 510(k) clearance K170871 for DigniCap Scalp Cooling System, Substantially Equivalent on 2017-07-03. Applicant: Dignitana AB. Device class: 2.

Clearance details

Applicant: Dignitana AB
Product code: Code PMC
Device class: Class 2
Regulation: 21 CFR 878.4360
Advisory panel: General, Plastic Surgery
Date received: 2017-03-23
Decision date: 2017-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lund, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code PMC

K252289 — Eva Scalp Cooling System2025-11-25
K211526 — Portable Scalp Cooling System2021-10-21
K191166 — DigniCap Delta2019-06-26
K173032 — Paxman Scalp Cooler2018-06-07
K163484 — Paxman Scalp Cooler2017-04-17

More clearances from Dignitana AB

DEN150010 — Dignitana AB DigniCap System2015-12-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.