Not Cleared Direct

DEN150010 - Dignitana AB DigniCap System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150010 · Dignitana AB · General & Plastic Surgery device
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Dec 2015
Decision
277d
Days
Class 2
Risk

DEN150010 is an FDA 510(k) submission (not cleared) for the Dignitana AB DigniCap System. Classified as Scalp Cooling System (product code PMC), Class II - Special Controls.

Submitted by Dignitana AB (Lund, SE). The FDA issued a Not Cleared (DENG) decision on December 8, 2015 after a review of 277 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4360 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 277 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Dignitana AB devices

Submission Details

510(k) Number DEN150010 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 06, 2015
Decision Date December 08, 2015
Days to Decision 277 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 114d · This submission: 277d
Pathway characteristics

Device Classification

Product Code PMC Scalp Cooling System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4360
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.