Skip to content

Butterfly II PN Infusion Needle

by Cosmetic Sciences, Inc.

510(k) K842756

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 NumberK842756 Date23 Jul 1984ClearedStatusActive

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  • Withdrawn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
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Butterfly II PN Infusion Needle is a hypodermic, single lumen needle designed for intravenous infusion procedures. It is intended for use in general hospital settings for the administration of fluids or medications directly into the bloodstream.

The device is supplied in sterile, individual packaging with a shelf life of up to 5 years when unopened. It is available in various sizes including 21G. The Butterfly II PN Infusion Needle received FDA 510(k) clearance with the number K842756 on July 23, 1984, and is classified under product code FMI.

Other devices from Cosmetic Sciences, Inc.

Questions

AI-generated answers, 1 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 Butterfly II PN Infusion Needle used for?

    The Butterfly II PN Infusion Needle is a hypodermic, single lumen needle designed for intravenous infusion procedures in general hospital settings for administering fluids or medications directly into the bloodstream.

  • How is the Butterfly II PN Infusion Needle supplied?

    The device is supplied in sterile, individual packaging with a shelf life of up to 5 years when unopened. It is available in various sizes including 21G.

  • What is the regulatory status of the Butterfly II PN Infusion Needle?

    The Butterfly II PN Infusion Needle received FDA 510(k) clearance with number K842756 on July 23, 1984, and is classified under product code FMI.

  • Is the Butterfly II PN Infusion Needle reusable?

    The device is designed for single-use in intravenous infusion procedures. It should not be reused due to sterility concerns and potential contamination risks.