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K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)

by Terumo Europe N.V.

510(k) K243581

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 NumberK243581 Date4 Apr 2025ClearedStatusActive

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  • Withdrawn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 K-Pack Enhance Needle is a hypodermic single lumen needle. It is classified as a Class II device and is regulated under 21 CFR 880.5570. The device is used in general hospital settings. It is a sterile needle, available in models KH-2713RBBTC and KH-2913RBBTC.

The K-Pack Enhance Needle is supplied sterile and is intended for single use. It has a product code of FMI and has been found to be substantially equivalent. The device has been assigned the 510(k) number K243581, with a decision date of April 4, 2025.

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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 Enhance Needle used for?

    The K-Pack Enhance Needle is used in general hospital settings as a hypodermic single lumen needle.

  • Is the K-Pack Enhance Needle sterile?

    Yes, the K-Pack Enhance Needle is supplied sterile and is intended for single use.

  • What models of the K-Pack Enhance Needle are available?

    The K-Pack Enhance Needle is available in models KH-2713RBBTC and KH-2913RBBTC.