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Covidien Extended Tip Applicator

by Confluent Surgical, Inc

510(k) K091315

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

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 NumberK091315 Date5 Jun 2009ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1958-2025 FDA Class I initiated 22 May 2025
    • Ongoing Z-1960-2025 FDA Class I initiated 22 May 2025
    • Ongoing Z-1959-2025 FDA Class I initiated 22 May 2025

    Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

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  • Withdrawn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
FMF
FDA applicant
Confluent Surgical,Inc
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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