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Light Saber Aspiration Needle

by Minrad, Inc.

510(k) K982018

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 NumberK982018 Date7 Aug 1998ClearedStatusActive

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  • Withdrawn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, 19 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 Light Saber Aspiration Needle is a single-use, disposable medical device classified as a needle, aspiration (FDA Product Code: FMF). It serves as a conduit for the injection or aspiration of fluids, facilitating precise fluid management in clinical procedures. Designed for attachment to a syringe, it enables controlled withdrawal or delivery of bodily fluids during medical interventions.

Used in hospital settings by healthcare professionals, the device is intended for sterile, single-use applications. It is regulated under FDA 510(k) clearance (K982018) and falls under the General Hospital advisory committee classification. The device is not reusable and must be stored in accordance with standard medical device protocols to maintain sterility and functionality.

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Questions

AI-generated answers, 19 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 Light Saber Aspiration Needle used for?

    The Light Saber Aspiration Needle is a single-use, disposable medical device that serves as a conduit for the injection or aspiration of fluids, facilitating precise fluid management in clinical procedures when attached to a syringe.

  • Is the Light Saber Aspiration Needle reusable?

    No, the Light Saber Aspiration Needle is designed for sterile, single-use applications only and is not intended to be reused.

  • How should the Light Saber Aspiration Needle be stored?

    The device must be stored in accordance with standard medical device protocols to maintain sterility and functionality.

  • What is the regulatory status of the Light Saber Aspiration Needle?

    The Light Saber Aspiration Needle is regulated under FDA 510(k) clearance (K982018) and is classified under the General Hospital advisory committee.