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Bi-3M Needle-Free Injector System

by Felton International, Inc. 510(k)

Active United States

510(k) K013256

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013256 Date7 Dec 2001ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KZE
Device Class
Class II
Regulation
21 CFR Part 880.5430
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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