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K-Pack II (Hypodermic Needle) 23g X 1, Model Kn-2325RB, K-Pack II Needle (Hypodermic Needle) 25g X 1, Model Kn-2525RB, K

by Terumo Europe N.V.

510(k) K984576

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 NumberK984576 Date14 Jun 1999ClearedStatusActive

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  • Withdrawn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
Models / Variants
K
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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