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NeoZoline NZ3213Blue

by Adept Medical Limited

NeoZoline NZ3213Blue is a tympanostomy tube (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Adept Medical Limited, cleared under FDA 510(k) K061058 on 12 Jul 2006 and listed in FDA GUDID since 25 Feb 2016 (UDI-DI 09421901970840), active as of 23 Oct 2026. 7 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

7 ongoing

This device is named in the recall

Documents

510(k) K061058

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 Number09421901970840 UDI-DI Date25 Feb 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061058 Date12 Jul 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061058 decided 12 Jul 2006 Active
  • FDA GUDID UDI-DI 09421901970840 listed 25 Feb 2016 Listed

Recalls

7 recalls · 7 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-0966-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0969-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0965-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0970-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0967-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0963-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0968-2025 FDA Class II initiated 24 Nov 2024

    Lack of 510(k) clearance.

Timeline

9 dated events

  1. Cleared FDA 510(k) K061058
  2. Listed FDA GUDID 09421901970840
  3. Recall initiated FDA recalls Z-0966-2025
  4. Recall initiated FDA recalls Z-0969-2025
  5. Recall initiated FDA recalls Z-0965-2025
  6. Recall initiated FDA recalls Z-0970-2025
  7. Recall initiated FDA recalls Z-0967-2025
  8. Recall initiated FDA recalls Z-0963-2025
  9. Recall initiated FDA recalls Z-0968-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NeoZoline
Generic name
Tympanostomy tube
Model / Ref / Catalog
NZ3213Blue
Primary DI / UDI-DI
09421901970840
510(k) Number
FDA product code
ETD
GMDN term
Tympanostomy tube
Device class
Class II
Regulation number
874.3880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tympanostomy tube

Cleared under the same submission (K061058)

and 8 more cleared under K061058

Similar devices in this category

Other devices filed under Tympanostomy tube.

Other devices from Adept Medical Limited

See all devices from Adept Medical Limited →

Properties

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