Aneuroplastic, Model 43-1290

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K071776 ↗

FDA Product Code

JXH

Device Class

Class II

Regulation

21 CFR Part 882.5030

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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• What is the Aneuroplastic 43-1290 used for in neurosurgery?

  The Aneuroplastic 43-1290 is designed specifically for aneurysmorrhaphy, the surgical treatment of cerebral aneurysms. It provides a rigid, durable seal within the aneurysm sac to prevent rupture by forming a stable barrier when polymerized in situ. This helps maintain vascular integrity during and after the procedure.

• How is the Aneuroplastic 43-1290 supplied and prepared for use?

  The Aneuroplastic 43-1290 is supplied as a sterile, single-use implant. It must be handled under sterile conditions and stored according to the manufacturer’s guidelines to preserve sterility. The device polymerizes in situ during use, so proper surgical technique is required to ensure effective sealing of the aneurysm sac.

• Is the Aneuroplastic 43-1290 reusable, or is it intended for one-time use?

  The Aneuroplastic 43-1290 is explicitly intended for single-use only. It is supplied sterile and designed to polymerize and form a permanent seal within the aneurysm sac. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and the integrity of the seal.

• What regulatory pathway does the Aneuroplastic 43-1290 follow?

  The Aneuroplastic 43-1290 is classified under FDA product code JXH and has received FDA 510(k) clearance (K071776) as a Class II medical device under Special Controls for Neurology applications. This clearance confirms its substantial equivalence to a predicate device and compliance with regulatory requirements for neurosurgical implants.

• How should the Aneuroplastic 43-1290 be stored to ensure proper functionality?

  The Aneuroplastic 43-1290 must be stored according to the manufacturer’s guidelines to maintain sterility and ensure the material remains stable before use. Improper storage conditions could affect polymerization or compromise the device’s integrity. Always follow the provided storage instructions to guarantee optimal performance during surgery.