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Beacon DSN-19-01

by Covidien LP

Ref DSN-19-01

Beacon DSN-19-01 is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 0763000B00014807Z), cleared under FDA 510(k) K103668 on 30 Dec 2010 and listed in FDA GUDID since 5 Sep 2026 (UDI-DI 10884521833142), active as of 24 Oct 2026. 5 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

5 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103668

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10884521833142 UDI-DI Date5 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0763000B00014807Z Basic UDI-DI 10884521833142UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103668 Date30 Dec 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00014807Z registered 3 Aug 2026 Active
  • FDA 510(k) K103668 decided 30 Dec 2010 Active
  • FDA GUDID UDI-DI 10884521833142 listed 5 Sep 2026 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

8 dated events

  1. Cleared FDA 510(k) K103668
  2. Recall initiated FDA recalls Z-1475-2017
  3. Recall initiated FDA recalls Z-1474-2017
  4. Recall initiated FDA recalls Z-1476-2017
  5. Recall initiated FDA recalls Z-1473-2017
  6. Recall initiated FDA recalls Z-1472-2017
  7. Registered EUDAMED 0763000B00014807Z
  8. Listed FDA GUDID 10884521833142

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Beacon™ EUDAMED
Beacon GUDID
Generic name
General-purpose endoscopic needle, single-use
Model / reference
DSN-19-01
Primary DI / UDI-DI
10884521833142
Basic UDI-DI
0763000B00014807Z
510(k) Number
FDA product code
FCG
EMDN code
A0199 Needles - other
GMDN term
General-purpose endoscopic needle, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 19 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)