Cleared Special

K071776 - ANEUROPLASTIC, MODEL 43-1290

K071776 is an FDA 510(k) clearance for ANEUROPLASTIC, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Neurology device with product code JXH cleared through the Special 510(k) pathway after a 27-day FDA review.

K071776 · Codman & Shurtleff, Inc. · Neurology device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Jul 2007

Decision

27d

Days

Class 2

Risk

K071776 is an FDA 510(k) clearance for the ANEUROPLASTIC, MODEL 43-1290. Classified as Methyl Methacrylate For Aneurysmorrhaphy (product code JXH), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on July 26, 2007 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5030 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071776

510(k) Number	K071776 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 29, 2007
Decision Date	July 26, 2007
Days to Decision	27 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

122d faster than avg

Panel avg: 149d · This submission: 27d

Pathway characteristics

Modification to existing cleared device.

JXH Device Classification - Class 2, Special Controls

Product Code	JXH Methyl Methacrylate For Aneurysmorrhaphy
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 882.5030

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXH Methyl Methacrylate For Aneurysmorrhaphy

Devices cleared under the same product code (JXH) and FDA review panel - the closest regulatory comparables to K071776.

ORTHOPAEDIC AND SPINAL RING CURRETTES

K882072 · Karlin Technology, Inc. · Jun 1988

ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL

K873688 · Dentsply Intl. · Oct 1987

FDA 510(k) Resources - Neurology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K071776

Codman & Shurtleff, Inc.

Raynham, MA · US

RACHEL CREME

Regulatory profile

152 submissions 151 cleared

99% clearance rate · Active in Neurology

View all devices by Codman & Shurtleff, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: July 26, 2007. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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