

# SGU · Neurovascular Liquid Embolic Agent

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/SGU

## Overview

- **Product Code:** SGU
- **Device Name:** Neurovascular Liquid Embolic Agent
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

Arterial occlusion of the middle meningeal artery for treatment of symptomatic subdural hematoma.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P250009](/device/P250009.md) | SQUID Liquid Embolic Agent (LEA) | Balt USA, LLC | Jan 30, 2026 | APPR |

## Top Applicants

- Balt USA, LLC — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/SGU](https://fda.innolitics.com/productcode/SGU)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
