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510(k) K130581

KONIX STERILE GEL by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2014
Date Received
March 5, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Coupling, Ultrasound
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa

  • K140506 — JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL (April 17, 2015)
  • K101952 — KONIX ULTRASOUND GEL (May 27, 2011)

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  • K232957 — Sterile and Non-Sterile Ultrasound Gels (December 15, 2023)
  • K221999 — Ultrasound Transmission Gels (August 30, 2022)
  • K211691 — Ultrast Gel (December 22, 2021)
  • K190591 — Safergel Sterile Ultrasound Gel (October 4, 2019)
  • K181363 — EcoVue Sterile and Non-Sterile Ultrasound Gels (June 13, 2018)
  • K163026 — Ultra/Phonic Scanning Gel (January 9, 2018)
  • K163027 — Ultra/Phonic Free Conductivity Gel (January 9, 2018)
  • K163023 — Other-Sonic Transmission Gel (January 8, 2018)