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Konix Sterile Lubricant Gel 11 Ml

by Turkuaz Sağlik Hi̇zmetleri̇ Medi̇kal Temi̇zli̇k Ki̇myasal Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

Ref SLG-0014

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

4 ongoing

Recall on shared 510(k) K130581; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130581↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08683229607476 Basic UDI-DI 08683229607476UDI-DIDate6 May 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK130581 Date18 Jun 2014IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

4 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2533-2023 FDA Class II initiated 7 Jul 2023 on shared 510(k) K130581
    • Ongoing Z-2532-2023 FDA Class II initiated 7 Jul 2023 on shared 510(k) K130581

    Ultrasound gel mislabeled with inappropriate use.

    • Ongoing Z-0777-2024 FDA Class II initiated 9 Jun 2023 on shared 510(k) K130581

    Sterility of Ultrasound gel can not be guaranteed.

    • Ongoing Z-2290-2023 FDA Class II initiated 15 May 2023 on shared 510(k) K130581

    Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device Name
Konix Sterile Lubricant Gel 11 Ml
Model / Reference
SLG-0014
Primary DI / UDI-DI
08683229607476
Basic UDI-DI
B-08683229607476
EMDN Code
M9002 Protective devices, lubricants and soothing devices (sprays, gels, fluids and creams)
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000015402

Other devices from Turkuaz Sağlik Hi̇zmetleri̇ Medi̇kal Temi̇zli̇k Ki̇myasal Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Turkuaz Sağlik Hi̇zmetleri̇ Medi̇kal Temi̇zli̇k Ki̇myasal Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No