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Bnx N-25-05

by Covidien LP

Bnx N-25-05 is a Class II device made by Covidien LP, cleared under FDA 510(k) K103668 on 30 Dec 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00855208005070), active as of 22 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

510(k) K103668

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00855208005070 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103668 Date30 Dec 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103668 decided 30 Dec 2010 Active
  • FDA GUDID UDI-DI 00855208005070 listed 24 Sep 2016 Listed

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.

Timeline

7 dated events

  1. Cleared FDA 510(k) K103668
  2. Listed FDA GUDID 00855208005070
  3. Recall initiated FDA recalls Z-1475-2017
  4. Recall initiated FDA recalls Z-1474-2017
  5. Recall initiated FDA recalls Z-1476-2017
  6. Recall initiated FDA recalls Z-1473-2017
  7. Recall initiated FDA recalls Z-1472-2017

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bnx
Generic name
General-purpose endoscopic needle, single-use
Model / reference
N-25-05
Primary DI / UDI-DI
00855208005070
510(k) Number
FDA product code
FCG
GMDN term
General-purpose endoscopic needle, single-use
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 25 Gauge

Related devices

Cleared under the same submission (K103668)

and 6 more cleared under K103668

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)