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Arrow IPN033813

by Teleflex Incorporated

Ref 9468-VC-006

Arrow IPN033813 (9468-VC-006) is a device classified as Class IIa in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI B-00816000012284), cleared under FDA 510(k) K142377 on 17 Dec 2014 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00816000012284), active as of 25 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142377

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816000012284 Basic UDI-DI 00816000012284UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816000012284 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK142377 Date17 Dec 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00816000012284 registered 10 Jul 2026 Active
  • FDA 510(k) K142377 decided 17 Dec 2014 Active
  • FDA GUDID UDI-DI 00816000012284 listed 16 Sep 2016 Listed

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0675-2017 FDA Class II initiated 8 Nov 2016 on shared 510(k) K142377
    • Terminated Z-0676-2017 FDA Class II initiated 8 Nov 2016 on shared 510(k) K142377
    • Terminated Z-0679-2017 FDA Class II initiated 8 Nov 2016 on shared 510(k) K142377
    • Terminated Z-0678-2017 FDA Class II initiated 8 Nov 2016 on shared 510(k) K142377

    Sterility: Due to a potential incomplete seal on the outer sterile package.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

7 dated events

  1. Cleared FDA 510(k) K142377
  2. Listed FDA GUDID 00816000012284
  3. Recall initiated FDA recalls Z-0675-2017
  4. Recall initiated FDA recalls Z-0676-2017
  5. Recall initiated FDA recalls Z-0679-2017
  6. Recall initiated FDA recalls Z-0678-2017
  7. Registered EUDAMED B-00816000012284

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
OnControl(R) Aspiration System Needle Set, 68mm EUDAMED
Arrow GUDID
Generic name
Bone marrow biopsy needle, single-use
Device name
Oncontrol Aspiration System Needle
Model / Ref / Catalog
9468-VC-006, IPN033813
Primary DI / UDI-DI
00816000012284
Basic UDI-DI
B-00816000012284
510(k) Number
FDA product code
FCG
EMDN code
A01020299 Needles and kits - bone marrow biopsy - other
GMDN term
Bone marrow biopsy needle, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Length — 68 Millimeter
Needle Gauge — 15 Gauge

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
9468-VC-006
GUDID
IPN033813
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bone marrow biopsy needle, single-use

Cleared under the same submission (K142377)

and 8 more cleared under K142377

Similar devices in this category

Other devices filed under BONE MARROW BIOPSY NEEDLES AND KITS.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)