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Needleless Injection Cannula

by Arrow Intl., Inc.

510(k) K923653

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923653 Date13 May 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LJS
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Needleless Injection Cannula is a catheter, intravascular, therapeutic device designed for long-term use greater than 30 days. It is intended for injection procedures without the use of traditional needles.

This device is supplied by Arrow Intl., Inc. and is FDA 510(k) cleared with product code LJS. It is regulated under device class 2 and is authorized for use in general hospital settings. The device includes multiple model numbers and registration numbers as specified in the authorization.

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Questions

AI-generated answers, 24 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 Needleless Injection Cannula used for?

    The Needleless Injection Cannula is a catheter, intravascular, therapeutic device designed for long-term use greater than 30 days. It is specifically intended for injection procedures without the use of traditional needles.

  • How is the Needleless Injection Cannula supplied?

    This device is supplied by Arrow Intl., Inc. and is available in multiple model numbers and registration numbers as specified in the FDA 510(k) authorization.

  • What is the regulatory status of the Needleless Injection Cannula?

    The device is FDA 510(k) cleared with product code LJS and is regulated under device class 2. It is authorized for use in general hospital settings and was cleared on May 13, 1993.

  • Is the Needleless Injection Cannula single-use or reusable?

    The device is designed for long-term use greater than 30 days, indicating it is intended for extended use rather than single-use applications.