# K103305: Penumbra Embolization Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Jan 26, 2011 after 78 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K951256 (1995). 34 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031049: Guglielmi Detachable Coil (GDC), Boston Scientific, Target (2003) Summary page 1.
- K093142: Target Detachable Coils and Inzone Detachment System, Boston Scientific Corp (2010) Summary page 1.

## Most influential descendants
- K120330: Penumbra Coil System/Penumbra Coil 400 (2012), 9 descendants of its own
- K143218: Penumbra Smart Coil (2015), 4 descendants of its own
- K151572: Penumbra Smart Coil (2015), 3 descendants of its own
- K160832: Penumbra Smart Coil (2016), 2 descendants of its own
- K192955: Penumbra LP Coil System (2019), 1 descendant of its own

## Recalls of this device
- Mar 4, 2011 · Not classified · Z-1906-2011: The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil.

## Indications for use
The Penumbra Coil System is indicated for the embolization of: Intracranial aneurysms Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae Arterial and venous embolizations in the peripheral vasculature

Source page: https://510kreport.com/device/K103305
Methodology: https://510kreport.com/methodology