Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5030](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5030) → JXH — Methyl Methacrylate For Aneurysmorrhaphy

# JXH · Methyl Methacrylate For Aneurysmorrhaphy

_Neurology · 21 CFR 882.5030 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXH

## Overview

- **Product Code:** JXH
- **Device Name:** Methyl Methacrylate For Aneurysmorrhaphy
- **Regulation:** [21 CFR 882.5030](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5030)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **Implant:** yes

## Identification

Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K071776](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXH/K071776.md) | ANEUROPLASTIC, MODEL 43-1290 | Codman & Shurtleff, Inc. | Jul 26, 2007 | SESE |
| [K882072](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXH/K882072.md) | ORTHOPAEDIC AND SPINAL RING CURRETTES | Karlin Technology, Inc. | Jun 17, 1988 | SESE |
| [K873688](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXH/K873688.md) | ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL | Dentsply Intl. | Oct 26, 1987 | SESE |

## Top Applicants

- Codman & Shurtleff, Inc. — 1 clearance
- Dentsply Intl. — 1 clearance
- Karlin Technology, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXH](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXH)

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