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Accu-Flo Pressure Valve

by Codman & Shurtleff, Inc. 510(k)

Active United States

510(k) K853215

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853215 Date16 Sep 1985ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JXG
Device Class
Class II
Regulation
21 CFR Part 882.5550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Accu-Flo Pressure Valve is a Class 2 neurology device with product code JXG, designed as a component of a central nervous system fluid shunt system. It is used to divert fluid from the brain or other part of the central nervous system to relieve elevated intracranial pressure or fluid volume, such as in cases of hydrocephalus.

The device is manufactured by Codman & Shurtleff, Inc. and received FDA 510(k) clearance through the Traditional pathway on September 16, 1985. It is supplied as a single component of a shunt system and is regulated under product code JXG. The device is not described as MRI safe, single-use, or reusable in the provided data.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ACCU-FLO Pressure Valve used for?

    The ACCU-FLO Pressure Valve is a component of a central nervous system fluid shunt system designed to divert fluid from the brain or other parts of the central nervous system to relieve elevated intracranial pressure or fluid volume, such as in cases of hydrocephalus.

  • How is the ACCU-FLO Pressure Valve supplied?

    The ACCU-FLO Pressure Valve is supplied as a single component of a shunt system. The device is manufactured by Codman & Shurtleff, Inc. and is not described as being MRI safe, single-use, or reusable in the provided data.

  • What is the regulatory status of the ACCU-FLO Pressure Valve?

    The ACCU-FLO Pressure Valve received FDA 510(k) clearance through the Traditional pathway on September 16, 1985. It is a Class 2 neurology device with product code JXG and is regulated under this classification.

  • What sizes and models of the ACCU-FLO Pressure Valve are available?

    The provided data does not specify different sizes or models of the ACCU-FLO Pressure Valve. It is described as a single component of a shunt system without details on variations in size or model options.