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Arrow IPN033784

by Teleflex Incorporated

Arrow IPN033784 (9408-VC-006) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K142377 on 17 Dec 2014 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 10816000012267), active as of 23 Oct 2026.

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

4 closed

Documents

510(k) K142377

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10816000012267 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142377 Date17 Dec 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142377 decided 17 Dec 2014 Active
  • FDA GUDID UDI-DI 10816000012267 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

6 dated events

  1. Cleared FDA 510(k) K142377
  2. Listed FDA GUDID 10816000012267
  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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arrow
Generic name
Bone marrow biopsy needle, single-use
Model / Ref / Catalog
IPN033784, 9408-VC-006
Primary DI / UDI-DI
10816000012267
510(k) Number
FDA product code
FCG
GMDN term
Bone marrow biopsy needle, single-use
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
Size
Length — 102 Millimeter
Needle Gauge — 11 Gauge

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 needle, single-use.

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 (10, all answered No)