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Bnx Fine Needle Aspiration System

by Boston Endoscopic Engineering 510(k)

Active United States

510(k) K103668

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103668 Date30 Dec 2010ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1475-2017 FDA Class II initiated 8 Feb 2017
    • Terminated Z-1474-2017 FDA Class II initiated 8 Feb 2017
    • Terminated Z-1476-2017 FDA Class II initiated 8 Feb 2017
    • Terminated Z-1473-2017 FDA Class II initiated 8 Feb 2017
    • Terminated Z-1472-2017 FDA Class II initiated 8 Feb 2017

    Handle may break during use.

Specification

510(k)

510(k) Number
FDA Product Code
FCG
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent