# K160832: Penumbra Smart Coil

- Pathway: 510(k) (Special)
- Applicant: Penumbra, Inc.
- Decided: Apr 20, 2016 after 26 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K951256 (1995). 38 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143218: Penumbra Smart Coil, Penumbra, Inc. (2015) Summary page 5.
- K151572: Penumbra Smart Coil, Penumbra, Inc. (2015) Summary page 5.

## Most influential descendants
- K192955: Penumbra LP Coil System (2019), 1 descendant of its own
- K230284: Penumbra LP Coil System (2023), 0 descendants of its own

## Indications for use
The Smart Coil 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/K160832
Methodology: https://510kreport.com/methodology