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Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml

by Conceptomed AS

510(k) K171805

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 · Special NumberK171805 Date8 Sep 2017ClearedStatusActive

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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The ConceptoMed Luer-Jack device is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration of fluids immediately after filling. It is a five-piece, single-use, sterile piston syringe available in 3 ml, 5 ml, 20 ml (Slip) and 10 ml (Lock) sizes.

The device is intended to be used only in combination with female 6% Luer connectors. It is supplied sterile and designated for single use. The device received FDA 510(k) clearance under K171805 with product code FMF and is classified as substantially equivalent.

Other devices from Conceptomed AS

Questions

AI-generated answers, 6 Oct 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 Luer-Jack syringe used for?

    The Luer-Jack syringe is intended for general purpose aspiration of fluids immediately after filling by health care professionals, designed for single use without a needle.

  • How is the Luer-Jack syringe supplied and is it sterile?

    The device is supplied sterile and designated for single use, ensuring it remains free from contamination until the point of use in clinical settings.

  • What sizes and types of Luer-Jack syringes are available?

    Available sizes include 3 ml, 5 ml, and 20 ml in Slip configuration, and 10 ml in Lock configuration, all as five-piece sterile piston syringes.

  • What connector type is required for the Luer-Jack syringe?

    The Luer-Jack syringe is intended to be used only in combination with female 6% Luer connectors for proper fluid aspiration and secure attachment.