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Painfusor Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111031

by Plan 1 Health, S.R.L.

Identifiers

510(k) Number
K111031 FDA 510(k)
FDA Product Code
BSO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5120 FDA 510(k)
Regulation Number
868.5120 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Painfusor Catheter is a radioopaque catheter designed for the continuous or intermittent delivery of medication, such as local anesthetics or narcotics. It features an advanced design to optimize uniform flow distribution and includes markings to identify the multi-holed section and distance from the beginning of the catheter.

The device is supplied with a peel-away introducer needle, dressing, and catheter fixation system. It is available in a range of 19 gauge sizes to accommodate various incision lengths. The Painfusor Catheter received FDA 510(k) clearance (K111031) on July 8, 2011, and is classified under product code BSO for anesthesiology applications.

Frequently asked questions

What is the Painfusor Catheter used for?

The Painfusor Catheter is designed for the continuous or intermittent delivery of medication, such as local anesthetics or narcotics, to provide targeted pain management during or after surgical procedures.

How is the Painfusor Catheter supplied and what components are included?

The device is supplied with a peel-away introducer needle, dressing, and catheter fixation system to support safe insertion, secure placement, and sterile handling during clinical use.

What sizes is the Painfusor Catheter available in and what does this accommodate?

The Painfusor Catheter is available in a range of 19 gauge sizes, allowing clinicians to select the appropriate diameter for various incision lengths and patient anatomies.

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: Painfusor - P1h, K111031 FDA 510(k) - PAINFUSOR CATHETER | Plan 1 Health, S.R.L., Plan 1 Health, S.R.L. FDA 510 (k) Products (2011-2011), Plan 1 Health S.r.l.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Plan 1 Health, S.R.L.

Sources (1)

  • FDA 510(k) K111031 24 fields · synced Oct 6, 2026