# K220040: CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jul 14, 2022 after 190 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K951256 (1995). 54 ancestors in all.
No later device cites it as a predicate yet.
1 of 55 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150319: Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant Microcoil Delivery Systems, Codman & Shurtleff, Inc. (2015) Summary page 4.

## Recalls of this device
- Oct 2, 2025 · Class I · Z-0434-2026: Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.

## Indications for use
The CEREPAKw Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, and Freeform Mini Detachable Coil Systems are indicated for embolization of intracranial aneurysms, neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature. The CEREPAKw Freeform XtraSoft Detachable Coil System is indicated for embolization of intracranial aneurysms.

Source page: https://510kreport.com/device/K220040
Methodology: https://510kreport.com/methodology