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Butterfly Needle Assembly

by Nu Tech Medical Systems

510(k) K812404

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 NumberK812404 Date9 Sep 1981ClearedStatusActive

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  • Withdrawn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, 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.

A Butterfly Needle Assembly is a hypodermic needle device with a single lumen, designed for subcutaneous infusion and tissue stabilization. It provides a flexible member to protect and stabilize the needle during insertion into patient tissues.

This device is supplied as a single-use assembly, cleared via FDA 510(k) under product code FMI with K number K812404. It is intended for use in general hospital settings and was determined substantially equivalent to a predicate device on September 9, 1981.

Other devices from Nu Tech Medical Systems

  • Infusion Pump

    Class II

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 Butterfly Needle Assembly intended for?

    The Butterfly Needle Assembly is a hypodermic needle device with a single lumen. It is designed for subcutaneous infusion and tissue stabilization, providing a flexible member to protect and stabilize the needle during insertion into patient tissues.

  • Is the Butterfly Needle Assembly intended for single use?

    Yes, the Butterfly Needle Assembly is supplied as a single-use assembly. This means it is designed for use on one patient and one procedure only.

  • How is the Butterfly Needle Assembly supplied?

    The device is supplied as a single-use assembly. It is intended for use in general hospital settings.

  • What is the regulatory status of the Butterfly Needle Assembly?

    The Butterfly Needle Assembly is cleared via FDA 510(k) under product code FMI with K number K812404. The device was determined substantially equivalent to a predicate device on September 9, 1981.