Skip to content

29G And 30G K-Pack Ii Needle

by Terumo Europe N.V.

510(k) K062608

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 NumberK062608 Date15 Sep 2006ClearedStatusActive

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  • Withdrawn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, 22 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 29G And 30G K-Pack Ii Needle is a hypodermic single lumen needle, a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from parts of the body. It is made of stainless steel containing nickel and cobalt. The device is designed for smooth injections of parenteral medications.

The 29G And 30G K-Pack Ii Needle is supplied sterile and is for single use. It is available in sizes 29G and 30G. The device has received FDA 510K clearance. It is manufactured by Terumo Europe N.V. and is intended for use in general hospital settings.

Other devices from Terumo Europe N.V.

See all devices from Terumo Europe N.V. →

Questions

AI-generated answers, 22 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 K-Pack II Needle used for?

    The K-Pack II Needle is intended to inject fluids into, or withdraw fluids from parts of the body, designed for smooth injections of parenteral medications.

  • Is the K-Pack II Needle sterile?

    Yes, the K-Pack II Needle is supplied sterile and is for single use, reducing the risk of infection.

  • What sizes is the K-Pack II Needle available in?

    The K-Pack II Needle is available in sizes 29G and 30G, providing options for different medical procedures.

  • What material is the K-Pack II Needle made of?

    The K-Pack II Needle is made of stainless steel containing nickel and cobalt, ensuring durability and resistance to corrosion.