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Acumed Flexible Cannula

FDA 510(k)

Class II (US FDA 510(k))

510(k) K932099

by Acu Med, Inc.

Identifiers

510(k) Number
K932099 FDA 510(k)
FDA Product Code
HRX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.1100 FDA 510(k)
Regulation Number
888.1100 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Acumed Flexible Cannula is a flexible orthopedic instrument classified under product code HRX, designed for surgical procedures requiring precise tissue access or bone penetration. Its flexible construction allows for navigation around anatomical obstacles, facilitating minimally invasive techniques in orthopedic applications. The device is intended for use in procedures where rigid cannulas may pose limitations due to structural constraints or patient anatomy.

Supplied as a single-use device, the Acumed Flexible Cannula is intended for sterile surgical environments and must be handled according to standard aseptic techniques. It is regulated under FDA 510(k) clearance (K932099) and falls under the Orthopedic advisory committee classification. No additional regulatory markings or MRI safety information are specified in the available data. Storage should follow manufacturer guidelines to maintain sterility and functionality prior to use.

Frequently asked questions

What is the Acumed Flexible Cannula used for in surgical procedures?

The Acumed Flexible Cannula is designed for orthopedic surgeries requiring precise tissue access or bone penetration. Its flexible design allows it to navigate around anatomical obstacles, making it particularly useful in minimally invasive techniques where rigid cannulas may be limited by patient anatomy or structural constraints.

Is the Acumed Flexible Cannula intended for single-use or reusable applications?

The Acumed Flexible Cannula is supplied as a single-use device. This classification ensures sterility and safety in sterile surgical environments, requiring adherence to standard aseptic techniques during handling and use.

What regulatory clearance does the Acumed Flexible Cannula hold?

The Acumed Flexible Cannula holds FDA 510(k) clearance under the reference number K932099. It is classified under product code HRX and falls under the Orthopedic advisory committee, with a decision of substantial equivalence to a predicate device.

How should the Acumed Flexible Cannula be stored before use?

The device should be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Proper storage conditions are critical to ensure the cannula remains intact and ready for use in surgical settings.

Does the Acumed Flexible Cannula have any specific MRI safety information?

The available data does not specify any MRI safety information for the Acumed Flexible Cannula. If MRI compatibility is a concern for your procedure, consult the manufacturer’s instructions or documentation for further clarification.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ACUMED FLEXIBLE CANNULA (K932099) — FDA 510 (k) | Innolitics, ASCent | Acumed Information, PDF K932099 - Acumed Flexible Cannula

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acu Med, Inc.

Sources (1)

  • FDA 510(k) K932099 24 fields · synced Oct 1, 2026