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510(k) K232957

Sterile and Non-Sterile Ultrasound Gels by Jianerkang Medical Co., Ltd. — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2023
Date Received
September 21, 2023
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 for product code MUI

  • K242167 — Sterile and Non-Sterile Ultrasonic Coupling Agent (September 19, 2024)
  • K241789 — Non-Sterile Ultrasound Transmission Gels (July 24, 2024)
  • 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)
  • K163027 — Ultra/Phonic Free Conductivity Gel (January 9, 2018)
  • K163026 — Ultra/Phonic Scanning Gel (January 9, 2018)
  • K163023 — Other-Sonic Transmission Gel (January 8, 2018)
  • K163024 — Ultra/Phonic Conductivity Gel (January 8, 2018)