# K220920: Matreneu Percutaneous Balloon Compression Kit

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Shineyard Medical Device Co., Ltd.
- Decided: Sep 7, 2022 after 161 days
- Product code: HAO (Instrument, Surgical, Non-Powered)
- Device class: 1
- Regulation: 21 CFR 882.4535
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940973 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940973: Mullan Ganglion Microcompression Set, Cook, Inc. (1995) Summary page 4.

## Indications for use
The Matreneu Percutaneous Balloon Compression Kit is intended to be used to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia.

Source page: https://510kreport.com/device/K220920
Methodology: https://510kreport.com/methodology